Slide-and-lock stent

ABSTRACT

The invention relates to an expandable stent comprising circumferentially adjacent modules. The modules comprise longitudinally adjacent slide-and-lock radial elements which permit one-way sliding of the radial elements from a collapsed diameter to an expanded/deployed diameter, but inhibit radial recoil from the expanded diameter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/016,269 filed on Dec. 17, 2004, and claims priority theretounder 35 U.S.C. §120.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to expandable medical implants for maintainingsupport of a body lumen.

2. Description of the Related Art

Stents or expandable grafts are implanted in a variety of body lumens inan effort to maintain their patency. These devices are typicallyintraluminally implanted by use of a catheter, which is inserted at aneasily accessible location and then advanced to the deployment site. Thestent is initially in a radially compressed or collapsed state to enableit to be maneuvered through the lumen. Once in position, the stent isdeployed which, depending on its configuration, may be achieved eitherautomatically or manually, by for example, the inflation of a balloonabout which the stent is carried on the catheter.

As stents are normally employed to hold open an otherwise blocked,constricted or occluded lumen, a stent must exhibit sufficient radial orhoop strength in its expanded state to effectively counter theanticipated forces. It is, however, simultaneously necessary for thestent to be as compact as possible in its collapsed state in order tofacilitate its advancement through the lumen. As a result, it isadvantageous for a stent to have as large an expansion ratio aspossible.

An additional consideration is the longitudinal flexibility of thedevice. Such characteristic is important not only in maneuvering thestent into position, which may require the traversal of substantialconvolutions of the vasculature, but also to better conform to anycurvature of the vasculature at the deployment site. At the same time itis, however, necessary for the stent to nonetheless exhibit sufficientradial strength to provide the necessary support for the lumen wallsupon deployment.

Another problem inherent in many prior art stent configurations is thelongitudinal contraction that such structures typically undergo as theyare radially expanded. This not only reduces the effective length of thestent in its deployed state but may cause abrasion trauma to beinflicted on the vessel walls during expansion.

A number of very different approaches have been previously devised in aneffort to address these various requirements. A popular approach callsfor the stent to be constructed wholly of wire. The wire is bent, wovenand/or coiled to define a generally cylindrical structure in aconfiguration that has the ability to undergo radial expansion. The useof wire has a number of disadvantages associated therewith including forexample, its substantially constant cross-section which may causegreater or lesser than an ideal amount of material to be concentrated atcertain locations along the stent. Additionally, wire has limitationswith respect to the shapes it can be formed into thus limiting theexpansion ratio, coverage area, flexibility and strength that canultimately be attained therewith.

As an alternative to wire-based structures, stents have been constructedfrom tube stock. By selectively removing material from such tubularstarting material, a desired degree of flexibility and expandability canbe imparted to the structure. Etching techniques as well aslaser-cutting processes are utilized to remove material from the tube.Laser cutting provides for a high degree of precision and accuracy withwhich very well defined patterns of material can be removed from thetube to conversely leave very precisely and accurately defined patternsof material in tact. The performance of such stent is very much afunction of the pattern of material which remains (i.e., design) andmaterial thickness. The selection of a particular pattern has a profoundeffect on the coverage area, expansion ratio and strength of theresulting stent as well as its longitudinal flexibility and longitudinaldimensional stability during expansion.

While the tube-based stents offer many advantages over the wire-baseddesigns, it is nonetheless desirable to improve upon such designs in aneffort to further enhance longitudinal flexibility and longitudinaldimensional stability during radial expansion without sacrificing radialhoop strength.

One stent design described by Fordenbacher, see e.g., U.S. Pat. Nos.5,549,662 and 5,733,328, employs a plurality of elongated parallel stentcomponents, each having a longitudinal backbone with a plurality ofopposing circumferential elements or fingers. The circumferentialelements from one stent component weave into paired slots in thelongitudinal backbone of an adjacent stent component. By incorporatinglocking means with the slotted articulation, the Fordenbacher stent mayminimize recoil after radial expansion. In addition, sufficient membersof circumferential elements in the Fordenbacher stent may provideadequate scaffolding. Unfortunately, the circumferential elements havefree ends, protruding from the paired slots. Moreover, thecircumferential elements weaving through the paired slots alsonecessarily stand off from the lumen wall. Both the free ends and thestand off may pose significant risks of thrombosis and/or-restenosis.Moreover, this stent design would tend to be rather inflexible as aresult of the plurality of longitudinal backbones.

Some stents employ “jelly roll” designs, wherein a sheet is rolled uponitself with a high degree of overlap in the collapsed state and adecreasing overlap as the stent unrolls to an expanded state. Examplesof such designs are described in U.S. Pat. Nos. 5,421,955 to Lau, U.S.Pat. Nos. 5,441,515 and 5,618,299 to Khosravi, and U.S. Pat. No.5,443,500 to Sigwart. The disadvantage of these designs is that theytend to exhibit very poor longitudinal flexibility. In a modified designthat exhibits improved longitudinal flexibility, multiple short rollsare coupled longitudinally. See e.g., U.S. Pat. Nos. 5,649,977 toCampbell and U.S. Pat. Nos. 5,643,314 and 5,735,872 to Carpenter.However, these coupled rolls lack vessel support between adjacent rolls.Furthermore, these designs exhibit extensive overlapping of stentelements in multiple layers, which makes the delivery profile ratherthick.

Various types of stents, including those referenced above, are oftendescribed based on their means for expansion. For additionalinformation, a variety of stents types are described by Balcon et al.,“Recommendations on Stent Manufacture, Implantation and Utilization,”European Heart Journal (1997), vol. 18, pages 1536-1547, and Phillips,et al., “The Stenter's Notebook,” Physician's Press (1998), Birmingham,Mich.

Balloon expandable stents are manufactured in the collapsed conditionand are expanded to a desired diameter with a balloon. The expandablestent structure may be held in the expanded condition by mechanicaldeformation of the stent as taught in, for example, U.S. Pat. No.4,733,665 to Palmaz. Alternatively, balloon expandable stents may beheld in the expanded condition by engagement of the stent walls withrespect to one another as disclosed in, for example, U.S. Pat. No.4,740,207 to Kreamer, U.S. Pat. No. 4,877,030 to Beck et al., and U.S.Pat. No. 5,007,926 to Derbyshire. Further still, the stent may be heldin the expanded condition by one-way engagement of the stent wallstogether with tissue growth into the stent, as disclosed in U.S. Pat.No. 5,059,211 to Stack et al.

Although balloon expandable stents are the first stent type to be widelyused in clinical applications, it is well recognized that balloonexpandable stents have a variety of shortcomings which may limit theireffectiveness in many important applications. For example, balloonexpandable stents often exhibit substantial recoil (i.e., a reduction indiameter) immediately following deflation of the inflatable balloon.Accordingly, it may be necessary to over-inflate the balloon duringdeployment of the stent to compensate for the subsequent recoil. This isdisadvantageous because it has been found that over-inflation may damagethe blood vessel. Furthermore, a deployed balloon expandable stent mayexhibit chronic recoil over time, thereby reducing the patency of thelumen. Still further, balloon expandable stents often exhibitforeshortening (i.e., a reduction in length) during expansion, therebycreating undesirable stresses along the vessel wall and making stentplacement less precise. Still further, many balloon expandable stents,such as the original Palmaz-Schatz stent and later variations, areconfigured with an expandable mesh having relatively jagged terminalprongs, which increases the risk of injury to the vessel, thrombosisand/or restenosis.

Self-expanding stents are manufactured with a diameter approximatelyequal to, or larger than, the vessel diameter and are collapsed andconstrained at a smaller diameter for delivery to the treatment site.Self-expanding stents are commonly placed within a sheath or sleeve toconstrain the stent in the collapsed condition during delivery. Afterthe treatment site is reached, the constraint mechanism is removed andthe stent self-expands to the expanded condition. Most commonly,self-expanding stents are made of Nitinol or other shape memory alloy.One of the first self-expanding stents used clinically is the braided“WallStent,” as described in U.S. Pat. No. 4,954,126 to Wallsten.Another example of a self-expanding stent is disclosed in U.S. Pat. No.5,192,307 to Wall wherein a stent-like prosthesis is formed of plasticor sheet metal that is expandable or contractible for placement.

Heat expandable stents are similar in nature to self-expanding stents.However, this type of stent utilizes the application of heat to produceexpansion of the stent structure. Stents of this type may be formed of ashape memory alloy, such as Nitinol or other materials, such aspolymers, that must go through a thermal transition to achieve adimensional change. Heat expandable stents are often delivered to theaffected area on a catheter capable of receiving a heated fluid. Heatedsaline or other fluid may be passed through the portion of the catheteron which the stent is located, thereby transferring heat to the stentand causing the stent to expand. However, heat expandable stents havenot gained widespread popularity due to the complexity of the devices,unreliable expansion properties and difficulties in maintaining thestent in its expanded state. Still further, it has been found that theapplication of heat during stent deployment may damage the blood vessel.

In summary, although a wide variety of stents have been proposed overthe years for maintaining the patency of a body lumen, none of theexisting schemes has been capable of overcoming most or all of the abovedescribed shortcomings. As a result, clinicians are forced to weighadvantages against shortcomings when selecting a stent type to use in aparticular application. Accordingly, there remains a need for animproved stent: one that is compact and flexible enough when collapsedto permit uncomplicated delivery to the affected area; one that issufficiently flexible upon deployment to conform to the shape of theaffected body lumen; one that expands uniformly to a desired diameter,without change in length; one that maintains the expanded size, withoutsignificant recoil; and one that has sufficient scaffolding to provide aclear through-lumen.

SUMMARY OF THE INVENTION

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention have been described herein above. Ofcourse, it is to be understood that not necessarily all such advantagesmay be achieved in accordance with any particular embodiment of theinvention. Thus, the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught or suggested herein without necessarily achieving otheradvantages as may be taught or suggested herein.

In one embodiment, a slide-and-lock stent is disclosed. The stentcomprises a tubular member having longitudinal and circumferential axes.The tubular member comprises at least two circumferentially adjacentmodules, each comprising at least two slide-and-lock radial elementswhich are separated from one another in the longitudinal axis by atleast one passive radial element, wherein each slide-and-lock radialelement comprises an engaging tab and a receiving slot which comprises alockout tooth therein and defines a travel path. The engaging tabs fromthe slide-and-lock radial elements from each module are slidably engagedwithin receiving slots in the slide-and-lock radial elements from acircumferentially adjacent module, wherein the lockout tooth isconfigured to permit one-way sliding of the tabs along the travel path,such that the tubular member achieves expansion in the circumferentialaxis with reduced recoil as the circumferentially adjacent modules slideapart from one another.

In preferred variations to the slide-and-lock stent, the travel path isaligned substantially in the circumferential axis.

In preferred variations to the slide-and-lock stent, the lockout toothfurther comprises a plurality of lockout teeth which are disposed alongboth proximal and distal sides of the slot. Preferably, the plurality oflockout teeth are substantially evenly distributed on the proximal anddistal sides of the slot. In another preferred variation, the lockoutteeth on the proximal side are circumferentially offset from the lockoutteeth on the distal side, such that the travel path defines a zig-zagpattern.

In preferred variations to the slide-and-lock stent, the passive radialelements further comprise a tab and a slot, wherein tabs from thepassive radial elements from each module are slidably engaged withinslots in the passive radial elements from a circumferentially adjacentmodule. Preferably, at least one slot from the passive radial elementshas a safety catch configured to stop the tab at a predeterminedlocation so as to prevent further sliding of the tab within the slot.

In yet another preferred variation to the slide-and-lock stent, at leastone of the slide-and-lock radial elements further comprises an actuatingcatch member configured to deflect from a non-actuated position to anactuated position and back again as it passes the lockout tooth duringexpansion. In one variation, the stent further comprises a positivereturn element adapted to return the actuating catch to the non-actuatedposition after passing the lockout tooth. Preferably, the lockout toothfurther comprises a plurality of lockout teeth which are disposed alongone side of the slot. In further variations, the stent comprises aplurality of positive return elements disposed along the other side ofthe slot from the lockout teeth and positioned so as to return theactuating catch to the non-actuated position after passing each of theplurality of lockout teeth.

In yet another preferred embodiment, at least one of the radial elementsfurther comprises a deformable region, such that radial expansion mayoccur through both sliding of circumferentially adjacent radial elementsand deformation of the deformable region.

In yet another preferred variation, an engaging tab is deflectable.

In yet another preferred variation, the stent further comprising alinkage region within a module, wherein the linkage region is configuredto facilitate material flexing. Preferably, the linkage region includesa structural feature selected from the group consisting of a U-shapedmember, inverted U-shaped member pairs, serpentine waves, linearconnectors disposed at an angle to the longitudinal and circumferentialaxes, and undulating spring elements.

In another preferred embodiment of the present invention, aslide-and-lock stent is disclosed comprising a tubular member havinglongitudinal and circumferential axes. The tubular member comprises afirst radial element comprising an actuating rail having an actuatordisposed thereron; a second radial element, circumferentially adjacentto the first radial element, and slidably engaged with the first radialelement, the second radial element comprising a deflectable catchelement; and a lockout catch, wherein the actuator is configured so thatas the second radial element slides relative to the first radialelement, the actuator deflects the deflectable catch element therebyengaging the lockout catch, such that the tubular member achievesexpansion in the circumferential axis with reduced recoil. Preferably,the lockout catch is disposed along a frame element which surrounds thefirst radial element.

In another preferred embodiment of the present invention, aslide-and-lock stent is disclosed comprising a tubular member havinglongitudinal and circumferential axes, wherein the tubular membercomprises a first radial element comprising a deflectable rail having alockout tooth disposed thereron; and a second radial element,circumferentially adjacent to the first radial element, and slidablyengaged with the first radial element, the second radial elementcomprising a slot, wherein the slot is configured to slidably engage anddeflect the deflectable rail as the lockout tooth disposed on thedeflectable rail passes through the slot, such that the tubular memberachieves expansion in the circumferential axis with reduced recoil.Preferably, the deflectable rail further comprises two rails with a gaptherebetween, wherein each rail has a plurality of lockout teethdisposed thereon.

In another preferred embodiment of the present invention, aslide-and-lock stent is disclosed comprising a tubular member havinglongitudinal and circumferential axes, wherein the tubular membercomprises: a first radial element comprising an elongate rail comprisinga deflectable tooth; and a second radial element, circumferentiallyadjacent to the first radial element, and comprising an engagement meansconfigured to slidably engage the elongate rail of the first radialelement and deflect the deflectable tooth as the tooth contacts theengagement means, such that the tubular member achieves expansion in thecircumferential axis with reduced recoil.

In preferred variations, the engagement means comprises a locking tabconfigured to slide adjacent to the elongate rail in the longitudinalaxis and deflect the tooth longitudinally toward the elongate rail.

In other preferred variations, the engagement means comprises a lockingtab configured to slide over or under the elongate rail and deflect thetooth toward the plane of the elongate rail.

In other preferred variations, the engagement means comprises a closedloop which defines a slot. Preferably, the elongate rail furthercomprises two rail members with a gap therebetween, such that the railmembers are configured to deflect toward one another into the gap whenengaged by the slot.

In other preferred variations, the radial elements have deflectableteeth and a closed loop wherein the radial elements of the stent areuniquely configured to include tapered sections in the circumferentialdirection in order to reduce the radial thickness of the stent at theoverlapping sections of circumferentially adjacent stent modules

In other preferred variations, the elongate rail has a plurality ofdeflectable teeth disposed thereon.

In other preferred variations, the slide-and-lock stent furthercomprises a first module comprising more than one of the first radialelements, linked to one another in the longitudinal axis, and secondmodule comprising more than one of the second radial elements, linked toone another in the longitudinal axis.

In other preferred variations, the longitudinally linked radial elementsin each module are circumferentially offset from one another in azig-zig pattern.

In another preferred embodiment of the present invention, aslide-and-lock stent is disclosed comprising a tubular member havinglongitudinal and circumferential axes, wherein the tubular membercomprises: a first radial element comprising a first serrated surface;and a second radial element, circumferentially adjacent to and slidablyengaged with said first radial element, and comprising a second serratedsurface, wherein the first and second serrated surfaces engage oneanother in a complimentary hill and valley configuration adapted toresist sliding, whereby once expanded by application of radial force,the tubular member resists recoil.

In preferred variations to the above-described stents, thelongitudinally adjacent radial elements are connected to one another bya flexible linkage element.

In another preferred embodiment of the present invention, aslide-and-lock stent is disclosed comprising a tubular member havinglongitudinal and circumferential axes, wherein the tubular membercomprises: a first module comprising at least two circumferentiallyoffset slide-and-lock radial elements and a coupling element, whereineach radial element comprises a tab, a gap comprising lockout teeth, anda slot; and a second module configured substantially identical to thefirst module and circumferentially adjacent to the first module, whereinthe radial elements from the second module are slidably engaged withinthe slots of the corresponding radial elements from the first module,and wherein the tabs of the radial elements from the second module areslidably engaged within the gaps of the corresponding radial elementsfrom the first module, such that the lockout teeth engage the tabs tominimize recoil.

In another preferred embodiment of the present invention, aslide-and-lock stent is disclosed comprising a tubular member havinglongitudinal and circumferential axes, wherein the tubular membercomprises: first and second longitudinal modules, each comprising peaksand valleys, wherein a protrusion comprising a lockout tooth extendsfrom a first peak in each module, and a slot extends through a locationalong a second peak in each module, wherein the protrusion from thefirst module is slidably engaged within the slot from the second module.

In preferred variations, the modules comprise (n) material layers,wherein (n) is at least two. Preferably, the protrusion and the locationeach comprise less than (n) material layers, and the total number ofmaterial layers at the location equals (n) when the protrusion from thefirst module is slidably engaged within the slot from the second module,such that the thickness of the slide-and-lock stent is uniform and doesnot exceed (n) layers.

In preferred variations to the above-described stents, a cross-sectionalgeometry of at least a portion of the stent is tapered so as to producegenerally desirable blood flow characteristics when the stent is placedin a blood vessel lumen.

In preferred variations to the above-described stents, the stent furthercomprises a material selected from the group consisting of metal andpolymer. Preferably, the polymer comprises a bioresorbable polymer. Morepreferably, the polymer comprises a radiopaque, bioresorbable polymer.In one aspect, the polymer forms a coating on at least a portion of thestent. The polymer coating may further comprise a biocompatible,bioresorbable polymer adapted to promote a selected biological response.

In preferred variations to the above-described stents, the stent furthercomprises a layered material. Preferably, the layered material comprisesa bioresorbable polymer.

In preferred variations to the above-described stents, the stent furthercomprises a therapeutic agent.

In preferred variations to the above-described stents, the stent furthercomprises a retractable sheath sized for enclosing the tubular memberduring delivery to a treatment site.

In preferred variations to the above-described stents, the stent furthercomprises a solid wall region. The solid wall region may furthercomprise an opening.

In preferred variations to the above-described stents, the stent furthercomprises a polymeric sheath.

A system for treating a site within a vessel is also disclosed. Thesystem comprises a catheter having a deployment means, and any of theabove-described stents, wherein the catheter is adapted to deliver thestent to the site and the deployment means is adapted to deploy thestent. In preferred variations, the catheter is selected from the groupconsisting of over-the-wire catheters, coaxial rapid-exchange catheters,and multi-exchange delivery catheters.

A method for re-treatment of a body lumen is disclosed in accordancewith another embodiment of the present invention. The method comprisesthe steps of: deploying to a region of the body lumen any of the abovedescribed stents, wherein the stent is made from a bioresorbablepolymer, and resides at the region for a period of time; andadministering to the region, after the period of time, a secondtreatment, such as for example, treatments selected from the groupconsisting of a second stent of any kind, angioplasty, arthrectomy,surgical bypass, radiation, ablation, local drug infusion, etc., or anysubsequent intervention or treatment.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments of the inventionwill become readily apparent to those skilled in the art from thefollowing detailed description of the preferred embodiments havingreference to the attached figures, the invention not being limited toany particular preferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus summarized the general nature of the invention and some ofits features and advantages, certain preferred embodiments andmodifications thereof will become apparent to those skilled in the artfrom the detailed description herein having reference to the figuresthat follow, of which:

FIG. 1 is a perspective partial view of a slide-and-lock stent in apartially expanded state having features and advantages in accordancewith one embodiment of the invention.

FIG. 2 is a perspective partial view of the stent of FIG. 1 in a moreexpanded state.

FIG. 3 is an enlarged planar view of a radial element of the stent ofFIG. 1 illustrating a path of travel during deployment.

FIG. 4 is a planar partial view of a module in accordance with onepreferred embodiment of a slide-and-lock stent, having passive radialelements with safety catches disposed in the longitudinal axis betweeneach slide-and-lock radial element.

FIG. 5 is a perspective partial view of a stent comprising the modulesof FIG. 4, illustrating the operation of a safety catch mechanism.

FIG. 6 is a planar partial view of a module having an actuatingslide-and-lock radial element with a deflectable catch mechanism andpositive return elements.

FIG. 7 is a planar view of a module having actuating slide-and-lockradial elements with deflectable catch mechanisms similar to FIG. 6, butwithout any positive return elements.

FIGS. 8 and 9 are planar partial views of an active lockout actuatingslide-and-lock mechanism. FIG. 8 shows the elements before actuation ofthe active lockout mechanism and FIG. 9 shows the elements afteractuation of the active lockout mechanism.

FIGS. 10 and 11 are planar partial views of a deformable slide-and-lockstent and its operation having features and advantages in accordancewith one embodiment of the invention. FIG. 10 shows the deformableportion in a collapsed state. FIG. 11 shows the deformable portion in anexpanded state.

FIG. 12 is a planar view of a module of the slide-and-lock stentincorporating deformable engaging tabs in accordance with one embodimentof the invention.

FIG. 13 is a perspective partial view of a slide-and-lock stentincorporating intra-modular flexible elements having features andadvantages in accordance with one embodiment of the invention.

FIG. 14 is a perspective partial view of a slide-and-lock stentincorporating intra-modular flexible elements having features andadvantages in accordance with another embodiment of the invention.

FIG. 15 is a planar partial view of a slide-and-lock stent incorporatingintra-modular flexible elements and split deflectable rails havingfeatures and advantages in accordance with another embodiment of theinvention.

FIGS. 16 and 17 are a planar partial views of a slide-and-lock stenthaving a frangible deployment control mechanism incorporated into apassive radial element in accordance with one embodiment of theinvention. FIG. 16 shows the deployment control mechanism before plasticdeformation of the frangible members and FIG. 17 shows the deploymentcontrol mechanism after plastic deformation of the frangible members.

FIG. 18 is a simplified schematic view of a stent strut geometryconfiguration designed to create generally laminar flow conditionshaving features and advantages in accordance with one embodiment of theinvention.

FIG. 19 is a simplified schematic view of another stent strut geometryconfiguration designed to create generally laminar flow conditionshaving features and advantages in accordance with another embodiment ofthe invention.

FIG. 20 is a simplified schematic view of a differential thickness stentstrut configuration designed to create generally laminar flowconditions, increase strength and reduce profile, having features andadvantages in accordance with one embodiment of the invention.

FIG. 21 is a simplified schematic view of a tapered overlap stent wallconfiguration designed to create generally laminar flow conditionshaving features and advantages in accordance with one embodiment of theinvention.

FIG. 22 is a plan view illustrating yet another preferred embodiment ofa row of radial elements wherein a solid wall is provided along a centerportion.

FIG. 23 illustrates a variation of the element of FIG. 22 wherein anopening is provided along the center portion of the solid wall forproviding fluid communication with a branch vessel.

FIG. 24 illustrates another variation of an expandable stent wherein anexpandable sheath is disposed over the expandable stent structure.

FIG. 25 illustrates an alternative structure comprising deflectableteeth which deflect inward to provide a stent exhibitingmono-directional expansion.

FIG. 26 illustrates another alternative structure comprising deflectableteeth which deflect downward to provide a stent exhibitingmono-directional expansion.

FIG. 27 illustrates a portion of a single element from the embodimentshown in FIG. 26.

FIG. 28A is a plan view illustrating another preferred embodiment of anexpandable stent comprising radial elements having deflectable teeth anda closed loop.

FIG. 28B illustrates the single module of FIG. 28A rolled into a partialtubular member.

FIG. 28C illustrates the articulation of two modules of FIG. 28Aslidably interlocked to form a partial tubular member.

FIG. 29 is a plan view illustrating another preferred embodiment of adeflectable tooth module comprising circumferentially offset radialelements.

FIG. 30A is a plan view illustrating an expandable stent modulecomprising radial elements having deflectable teeth and a closed taperedloop corresponding to a tapered upper and lower portions of the radialelement.

FIG. 30B illustrates the articulation of two modules of FIG. 30Aslidably interlocked to form a tubular member.

FIG. 30C is an end view of the tubular member illustrated in FIG. 30Billustrating the interconnection of the closed tapered loop and thetapered upper and lower portions of the radial element.

FIG. 31 illustrates another alternative structure comprising a singletab and series of shaped ridges that provide a stent exhibitingmono-directional expansion.

FIG. 32 illustrates another alternative structure comprising a row ofstaggered radial elements that may be interconnected with similarstructures to form an expandable stent.

FIG. 33A is a plan view illustrating slidably interconnected radialelements of the type illustrated in FIG. 32 which are constrained in thecollapsed condition.

FIG. 33B is a plan view illustrating slidably interconnected radialelements of the type illustrated in FIG. 32 which are locked-out in theexpanded condition.

FIG. 34 is a perspective view illustrating another preferred embodimentof an expandable stent comprising a plurality of interconnected flexiblerows.

FIG. 34A is a plan view illustrating a single flexible row from thestent embodiment of FIG. 34.

FIG. 35 is a perspective view illustrating yet another preferredembodiment of an expandable stent comprising a plurality ofinterconnected flexible rows.

FIG. 35A is a plan view illustrating a single flexible row from thestent embodiment of FIG. 35.

FIG. 36A is a plan view illustrating another preferred embodiment of anexpandable stent comprising a single element that may be rolled ontoitself to form a tubular member.

FIG. 36B illustrates the single element of FIG. 36A rolled into atubular member and constrained in the collapsed condition.

FIG. 36C illustrates the single element of FIG. 36A locked out in theexpanded condition.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The preferred embodiments of the invention described herein relategenerally to expandable medical implants for maintaining support of abody lumen. Embodiments and attributes of the invention include, but arenot limited to, a non-actuating slide-and-lock stent with radialelements following a defined path geometry having both radial and axialtranslation; a slide-and-lock stent with longitudinal modules comprisingboth active (slide-and-lock) and passive radial elements wherein theradial elements have a variety of features including, but not limitedto, spring elements, frangible deployment control mechanism and deviceoverextension safety catches; a slide-and-lock stent with non-symmetriclockout geometries for enhanced sizing resolution; an actuatingslide-and-lock stent with a positive lockout mechanism return; anactuating slide-and-lock stent with an active lockout system; adeformable slide-and-lock stent which provides additional device radialexpansion and/or increases device safety; a slide-and-lock stent withtwo sided lockout features; a crimpable slide-and-lock stent forenhanced retention on a delivery balloon; a crush recoverableslide-and-lock stent; and a slide-and-lock stent with optimized strut orwall configuration to reduce turbulence and create generally laminarflow of the blood. Further embodiments include a slide-and-lock stentwith a region with a high surface area region for support; aslide-and-lock stent with a region with a side-branch vessel accessport; and, a slide-and-lock stent with a graft covering. Furtherembodiments include a slide-and-lock stent comprised of a biocompatiblematerial (metal and/or polymer) and a slide-and-lock stent comprised oflayered materials and/or spatially localized materials. Furtherembodiments include a expandable slide-and-lock stent module comprisingradial elements having deflectable teeth and a closed loop wherein theradial elements of the stent are uniquely configured to include taperedsections in the circumferential direction in order to reduce the radialthickness of the stent at the overlapping sections of circumferentiallyadjacent stent modules.

While the description sets forth various embodiment specific details, itwill be appreciated that the description is illustrative only and shouldnot be construed in any way as limiting the invention. Furthermore,various applications of the invention, and modifications thereto, whichmay occur to those who are skilled in the art, are also encompassed bythe general concepts described herein.

The term “stent” is used herein to designate embodiments for placementin (1) vascular body lumens (i.e., arteries and/or veins) such ascoronary vessels, neurovascular vessels and peripheral vessels forinstance renal, iliac, femoral, popliteal, subclavian and carotid; andin (2) nonvascular body lumens such as those treated currently i.e.,digestive lumens (e.g., gastrointestinal, duodenum and esophagus,biliary ducts), respiratory lumens (e.g., tracheal and bronchial), andurinary lumens (e.g., urethra); (3) additionally such embodiments may beuseful in lumens of other body systems such as the reproductive,endocrine, hematopoietic and/or the integumentary,musculoskeletal/orthopedic and nervous systems (including auditory andophthalmic applications); and, (4) finally, stent embodiments may beuseful for expanding an obstructed lumen and for inducing an obstruction(e.g., as in the case of aneurysms).

In the following description of the present invention, the term “stent”may be used interchangeably with the term “prosthesis” and should beinterpreted broadly to include a wide variety of devices configured forsupporting a segment of a body passageway. Furthermore, it should beunderstood that the term “body passageway” encompasses any lumen or ductwithin a body, such as those described herein.

Still further, it should be understood that the term “shape-memorymaterial” is a broad term that includes a variety of known shape memoryalloys, such as nickel-titanium alloys, as well as any other materialsthat return to a previously defined shape after undergoing substantialplastic deformation.

In one preferred embodiment of the present invention, the assembledstent generally comprises a tubular member having a length in thelongitudinal axis and a diameter in the radial or circumferential axissized for insertion into the body lumen. The tubular member ispreferably formed with a “clear through-lumen,” which is defined ashaving little or no structure protruding into the lumen in either thecollapsed or expanded condition.

In many of the embodiments illustrated and described herein, theintraluminal stent is preferably provided with “slide-and-lock elements”generally referred to herein as “radial elements.” The radial elementsare slidably interconnected with circumferentially adjacent radialelements in a manner wherein the stent exhibits mono-directional radialexpansion from a radially collapsed state to a radially expanded state,e.g., during deployment. The radial elements are preferably configuredto provide a ratcheting effect such that the stent is maintained (i.e.,“locked-out”) in the expanded diameter after deployment within the bodypassage. More particularly, the structures (e.g., radial elements) mayflex or bend; however, unlike conventional balloon expandable stents, nosubstantial plastic deformation of the elements are required duringexpansion of the stent from a collapsed diameter to an expandeddiameter. Elements of this type are generally referred to herein as“non-deforming elements.” Accordingly, the term “non-deforming element”is intended to generally describe a structure that substantiallymaintains its original dimensions (i.e., length and width) duringdeployment of the stent. Each radial element is preferably formed as aflat sheet that is cut or otherwise shaped to provide a slide-and-lockmechanism.

The term “radial strength,” as used herein, describes the externalpressure that a stent is able to withstand without incurring clinicallysignificant damage. Due to their high radial strength, balloonexpandable stents are commonly used in the coronary arteries to ensurepatency of the vessel. During deployment in a body lumen, the inflationof the balloon can be regulated for expanding the stent to a particulardesired diameter. Accordingly, balloon expandable stents may be used inapplications wherein precise placement and sizing are important. Balloonexpandable stents may be used for direct stenting applications, wherethere is no pre-dilation of the vessel before stent deployment, or inprosthetic applications, following a pre-dilation procedure (e.g.,balloon angioplasty). During direct stenting, the expansion of theinflatable balloon dilates the vessel while also expanding the stent.

In another preferred embodiment, the stent further comprises a tubularmember formed from a biocompatible and preferably, bioresorbablepolymer, such as those disclosed in co-pending US Application No.10/952,202; incorporated herein in its entirety by reference. It is alsounderstood that the various polymer formulae employed may includehomopolymers and heteropolymers, which includes stereoisomers.Homopolymer is used herein to designate a polymer comprised of all thesame type of monomers. Heteropolymer is used herein to designate apolymer comprised of two or more different types of monomer which isalso called a co-polymer. A heteropolymer or co-polymer may be of a kindknown as block, random and alternating. Further with respect to thepresentation of the various polymer formulae, products according toembodiments of the present invention may be comprised of a homopolymer,heteropolymer and/or a blend of such polymers.

The term “bioresorbable” is used herein to designate polymers thatundergo biodegradation (through the action of water and/or enzymes to bechemically degraded) and at least some of the degradation products areeliminated and/or absorbed by the body. The term “radiopaque” is usedherein to designate an object or material comprising the object visibleby in vivo analysis techniques for imaging such as, but not limited to,methods such as x-ray radiography, fluoroscopy, other forms ofradiation, MRI, electromagnetic energy, structural imaging (such ascomputed or computerized tomography), and functional imaging (such asultrasonography). The term, “inherently radiopaque”, is used herein todesignate polymer that is intrinsically radiopaque due to the covalentbonding of halogen species to the polymer. Accordingly, the term doesencompass a polymer which is simply blended with a halogenated speciesor other radiopacifying agents such as metals and their complexes.

In another preferred variation, the stent further comprises an amount ofa therapeutic agent (for example, a pharmaceutical agent and/or abiologic agent) sufficient to exert a selected therapeutic effect. Theterm “pharmaceutical agent”, as used herein, encompasses a substanceintended for mitigation, treatment, or prevention of disease thatstimulates a specific physiologic (metabolic) response. The term“biological agent”, as used herein, encompasses any substance thatpossesses structural and/or functional activity in a biological system,including without limitation, organ, tissue or cell based derivatives,cells, viruses, vectors, nucleic acids (animal, plant, microbial, andviral) that are natural and recombinant and synthetic in origin and ofany sequence and size, antibodies, polynucleotides, oligonucleotides,cDNA's, oncogenes, proteins, peptides, amino acids, lipoproteins,glycoproteins, lipids, carbohydrates, polysaccharides, lipids,liposomes, or other cellular components or organelles for instancereceptors and ligands. Further the term “biological agent”, as usedherein, includes virus, serum, toxin, antitoxin, vaccine, blood, bloodcomponent or derivative, allergenic product, or analogous product, orarsphenamine or its derivatives (or any trivalent organic arseniccompound) applicable to the prevention, treatment, or cure of diseasesor injuries of man (per Section 351(a) of the Public Health Service Act(42 U.S.C. 262(a)). Further the term “biological agent” may include 1)“biomolecule”, as used herein, encompassing a biologically activepeptide, protein, carbohydrate, vitamin, lipid, or nucleic acid producedby and purified from naturally occurring or recombinant organisms,tissues or cell lines or synthetic analogs of such molecules, includingantibodies, growth factors, interleukins and interferons; 2) “geneticmaterial” as used herein, encompassing nucleic acid (eitherdeoxyribonucleic acid (DNA) or ribonucleic acid (RNA), genetic element,gene, factor, allele, operon, structural gene, regulator gene, operatorgene, gene complement, genome, genetic code, codon, anticodon, messengerRNA (mRNA), transfer RNA (tRNA), ribosomal extrachromosomal geneticelement, plasmagene, plasmid, transposon, gene mutation, gene sequence,exon, intron, and, 3) “processed biologics”, as used herein, such ascells, tissues or organs that have undergone manipulation. Thetherapeutic agent may also include vitamin or mineral substances orother natural elements.

In some embodiments, the design features of the radial elements can bevaried to customize the functional features of strength, compliance,radius of curvature at deployment and expansion ratio. In someembodiments, the stent comprises a resorbable material and vanishes whenits job is done. In some embodiments, the stent serves as a therapeuticdelivery platform.

The stent preferably comprises at least one longitudinal module, whichconsists of a series of radial elements, including one or moreslide-and-lock radial elements and optionally one or more passive radialelements, linked in the longitudinal axis by flexible coupling portions.Preferably, the radial elements from two or more similar longitudinalmodules are slidably connected to circumferentially adjacent radialelements. Of course, single module (or jellyroll-type) embodiments arealso encompassed within the scope of the present disclosure. Each moduleis preferably a discrete, unitary structure that does not stretch orotherwise exhibit any substantial permanent deformation during stentdeployment.

Some embodiments relate to a radially expandable stent used to open, orto expand a targeted area in a body lumen. In some embodiments, theassembled stent comprises a tubular member having a length in thelongitudinal axis and a diameter in the circumferential or radial axis,of appropriate size to be inserted into the body lumen. The length anddiameter of the tubular member may vary considerably for deployment indifferent selected target lumens depending on the number andconfiguration of the structural components, described below. The tubularmember is adjustable from at least a first collapsed diameter to atleast a second expanded diameter. One or more stops and engagingelements or tabs are incorporated into the structural components of thetubular member whereby recoil (i.e., collapse from an expanded diameterto a more collapsed diameter) is minimized to less than about 5%.

The tubular member in accordance with some embodiments has a “clearthrough-lumen,” which is defined as having no structural elementsprotruding into the lumen in either the collapsed or expanded diameters.Further, the tubular member has smooth marginal edges to minimize thetrauma of edge effects. The tubular member is preferably thin-walled(wall thickness depending on the selected materials ranging from lessthan about 0.010 inches for plastic and degradable materials to lessthan about 0.002 inches for metal materials) and flexible (e.g., lessthan about 0.01 Newtons force/millimeter deflection) to facilitatedelivery to small vessels and through tortuous vasculature.

Stents according to aspects of the present invention are preferablyformed with walls for providing a low crossing profile and for allowingexcellent longitudinal flexibility. In preferred embodiments, the wallthickness is about 0.0001 inches to about 0.0250 inches, and morepreferably about 0.0010 to about 0.0100 inches. However, the wallthickness depends, at least in part, on the selected material. Forexample, the thickness may be less than about 0.0060 inches for plasticand degradable materials and may be less than about 0.0020 inches formetal materials. More particularly, for a 3.00 mm stent application,when a plastic material is used, the thickness is preferably in therange of about 0.0040 inches to about 0.0045 inches. However, a stenthaving various diameters may employ different thicknesses for biliaryand other peripheral vascular applications. The above thickness rangeshave been found to provide preferred characteristics through all aspectsof the device including assembly and deployment. However, it will beappreciated that the above thickness ranges should not be limiting withrespect to the scope of the invention and that the teachings of thepresent invention may be applied to devices having dimensions notdiscussed herein.

Some aspects of embodiments of stents are disclosed in U.S. Pat. Nos.6,033,436, 6,224,626 and 6,623,521; each of which is hereby incorporatedin its entirety by reference thereto. Some aspects are also disclosed inco-pending U.S. Patent Application Nos. 60/601,526, 10/655,338,10/773,756, 10/897,235; each of which is incorporated herein in itsentirety by reference thereto.

Embodiments and Design Features of the Vascular Prosthesis

Preferred embodiments of a vascular prosthesis device or stent aredisclosed herein. These embodiments teach unique design attributes andfeatures that can be used in conjunction with a wide range of vascularprostheses or stents including embodiments of stents disclosed, taughtor suggested herein, and/or prior art stents.

Preferred embodiments and additional design attributes and featuresallow for further improvement and optimization in vascular prosthesisdevices or stents. The embodiments disclose novel geometries andmechanisms for vascular prosthesis devices or stents. These embodimentsand attributes can be utilized individually or in combination to achievedesired optimum device performance and characteristics. Attributes ofthese embodiments are not limited to a particular material. Devices orattributes may be prepared from a variety of materials, including butnot limited to, metals and polymers, including layers thereof, or anycombination thereof, and any of the materials or combinations thereofdisclosed, taught or suggested herein.

As used herein, one or more radial elements linked to one another in thelongitudinal axis forms a module. The slidable interlocking of one ormore modules in the circumferential axis forms a stent or vascularprosthesis. The stent is expandable via a sliding or articulatingmechanism to allow variation in the stent diameter. The number of radialelements in a module and the number of modules comprising the stent canbe efficaciously varied to provide for customization in the stent designand enhanced design versatility. Because longitudinally adjacent radialelements within a module are pre-linked (e.g., cut out of a single pieceof material) in some preferred embodiments disclosed herein, there is noneed to weld and/or otherwise connect the radial elements within amodule. Likewise, radial elements from circumferentially adjacentmodules are preferably interlinked (e.g., via insertion of tabs or railswithin slots) during assembly without any welding and/or other fixedconnections.

As detailed herein, various methods and techniques may be used tofabricate or manufacture the stents of embodiments of the invention.These include injection molding, laser machining, laser cutting, laserablation, die-cutting, chemical etching, plasma etching or other methodsknown in the art which are capable of producing high-resolutioncomponents. In some embodiments, the stent is fabricated from abiodegradable material.

The stents and prostheses of embodiments of the invention can have manyapplications and can be utilized in various techniques and incombination with other procedures, some of which are disclosed herein.One use of the stents is coronary stenting applications. The stentingcan be performed in conjunction with other catheter-based procedures,such as balloon angioplasty or artherectomy. The stents typically allowfor an excellent final result to be obtained with little to no narrowingremaining within the coronary arteries. By performing a stent insertionalong with other procedures, such as balloon angioplasty orartherectomy, the risk of the artery re-closing (restenosis) is greatlyreduced.

Various polymer materials may be used in conjunction with the stents, asdescribed herein such as in the sections “Polymeric Stents” and“Differential Layered and Spatially Localized Vascular Prosthesis.”Various therapeutic agents may also be incorporated into the stents asdescribed as in these sections.

If desired for a particular application, embodiments of the presentinvention may be used with a delivery sheath to constrain the stent inthe collapsed condition and to protect the inner wall of the vesselduring stent delivery. For example, a retractable delivery sheath may beconfigured for enclosing the stent during delivery. After the treatmentsite is reached, the sheath is withdrawn to expose the stent.

In an alternative configuration, the stents may be used in combinationwith a covering or sheath to provide a vessel graft. Different regionsof the stent may exhibit different expanded diameter, and the actualnumber and dimensions of the radial elements may vary. The lockingmechanism may also be releasable.

It will be appreciated by those skilled in the art that the basic designof a series of slide-and-lock radial elements provides the manufacturerwith a great deal of flexibility with regard to the collapsed andexpanded diameters of the stent as well as the longitudinal length.Increased expanded diameter and expansion ratio can be achieved byincreasing the number of modules, e.g., the number of slidablyinterconnected radial elements that comprise the circumference of thetubular member. Increased longitudinal length can be achieved byincreasing the number of radial elements within a module.

In another variation of the embodiments of the stent, different regionswithin the stent may exhibit different expanded diameters, such that thestent may be adjustable to different luminal states along the length ofthe stent. Accordingly, the stent may exhibit a tapered configuration inits deployed state, having a larger diameter at one end with progressiveor step-wise decreases in expanded diameter moving toward the other endof the stent.

It will be appreciated by those of skill in the art that theinterlocking and sliding radial element design of embodiments of theinvention provides the manufacturer with substantial flexibility incustomizing the stent for different applications. Because overlap ofstent components is minimized by the nesting frame elements, thecollapsed profile can be very thin without compromising radial strength.Moreover, the degree of overlap does not change substantially duringexpansion, unlike jelly-roll designs which expand by unraveling of arolled sheet. Furthermore, the deployment flexibility of the stent ofembodiments of the invention can be customized by changing the length,configuration and number of radial elements employed. Thus, a veryflexible and ultra-thin embodiment of the stent is deemed to be uniquelysuited for deployment in small and difficult to reach vessels, such asthe intercranial vessels distal to the carotids and the remote coronaryvessels.

The construction of the stent in this fashion provides a great deal ofbenefit over the prior art. The construction of the locking mechanism islargely material-independent. This allows the structure of the stent tocomprise high strength materials, not possible with designs that requiredeformation of the material to complete the locking mechanism. Theincorporation of these materials will allow the thickness required ofthe material to decrease, while retaining the strength characteristicsof thicker stents. In preferred embodiments, the frequency andarrangement of locking holes, stops or teeth present on selectedelements prevents unnecessary recoil of the stent subsequent toexpansion.

In any of the embodiments taught or suggested herein, materials may beused that exhibit clinical visibility (radiopacity), e.g., byincorporation of iodine or bromine or other radiopaque elements, use ofiodine-containing or other contrast agents. Materials may benon-resorbable polymers or radiopaque constituents of metalparticulates, bands or even liquid gold. Methods for viewing mayinclude, but are not limited to, x-ray, fluoroscopy, ultrasound, MRI, orImatron Electron Beam Tomography (EBT).

Non-Actuating Slide-and-Lock Device Design

FIGS. 1-3 show partial views of a slide-and-lock stent or vascularprosthesis device 10 in accordance with one embodiment of the presentinvention. FIG. 1 shows the stent 10 in a partially-expanded state andFIG. 2 shows the stent 10 in an expanded state.

The embodiment illustrated in FIGS. 1-3 is a slide-and-lock stent device10 that employs no actuating (that is, flexing, bending, and the like)elements to achieve expansion and lockout.

FIGS. 1 and 2 show partial views of two circumferentially adjacentmodules 12′ and 12″, each having longitudinally offset slide-and-lockradial elements, 14′ and 16′ in module 12′, and 14″ and 16″ in module12″. Modules generally have at least two (2) slide-and-lock radialelements, at proximal and distal ends of the module. These are sometimesreferred to as mechanism radial elements, because they comprise theslide-and-lock mechanisms that provide controlled deployment and resistradial compression. In preferred embodiments of these modules, there arebetween 2 and 8 slide-and-lock radial elements, and more preferably,between 2 and 4 slide-and-lock radial elements per module.

In some embodiments, such as that illustrated in FIGS. 1-3, thelongitudinally offset slide-and-lock radial elements within a module areseparated and interconnected by one or more passive radial elements,such as the two (2) passive radial elements 18 shown in FIGS. 1 and 2.These passive radial elements are sometimes referred to as non-mechanismradial elements because they do not contribute to the slide-and-lockmechanism of radial expansion, like the slide-and-lock radial elements.In some embodiments, there are no passive radial elements. In otherembodiments, there are from 1 to 8 passive radial elements disposedbetween each slide-and-lock radial element. More preferably, there arefrom 1 to 4 passive radial elements disposed between each slide-and-lockradial element in a module. As disclosed in greater detail below, thesepassive, non-mechanism radial elements can be engineered in manydifferent geometric configurations to provide inter alia variableflexibility, variable radial strength, variable scaffolding (vessel wallcoverage), and/or a safety catch to prevent over-expansion.

As can be seen in FIGS. 1 and 2, a tab 20 on each slide-and-lock radialelement (shown here on 16″) is slidably engaged within a slot 22 in thecircumferentially adjacent slide-and-lock radial element (shown here in16′). The entire circumference of stent 10 may comprise from 1 to 8circumferentially adjacent modules, more preferably from 2 to 6circumferentially adjacent radial elements, and most preferably from 2to 4 circumferentially adjacent radial elements.

As best seen in FIG. 3, a slide-and-lock radial element 14 has a slot 22with lockout teeth, catches or stops 24. When a tab 20 is slidablyengaged within a slot 22 from a circumferentially adjacentslide-and-lock radial element, it can travel within the slot 22—therebytraveling through a defined travel path, as generally indicated by arrow26 in FIG. 3. The travel path may be disposed substantially in thecircumferential axis as shown, or in some embodiments, the travel pathmay traverse both circumferential and longitudinal axes. Advantageously,the slot 22, stop 24, and tab 20 configurations allow for expansion thatachieves radial expansion while restricting travel in the oppositedirection. Defined path geometry can easily be altered to achieve avariety of device performance attributes, for example, lower/higherdeployment pressures and the like, among others.

In the illustrated embodiment of the slot 22 shown in FIG. 3, the stops24 are circumferentially offset from one another and disposed onalternating proximal 28 and distal 30 sides or walls of the slot.Further, the illustrated catches 24 are configured so as to allow thetab 20 to slide past each stop, translating simultaneously in thelongitudinal (axial) and circumferential (radial) axes, while movingalong the travel path 26. However, the stop 24 is configured to preventthe tab 20 from moving backwards along the travel path 26. Theslide-and-lock mechanism illustrated in FIGS. 1-3 does not involvematerial bending or deformation of the stent materials. Of course, otherslot 22, stop 24, and tab 20 configurations are encompassed withinpreferred embodiments of the invention, as long as they facilitateone-way sliding of the tab 20 within the slot 22. Further examples ofdifferent slot and stop configurations are disclosed with reference toFIGS. 4-16. The configurations disclosed herein are generally designedto allow one-way sliding to a more expanded circumference, whilepreventing significant recoil.

In the illustrated embodiment (FIGS. 1-3), there are also frame elements32 (shown in FIG. 3), which surround the radial element 14. In somepreferred embodiments, there are no frame elements. In others, as shown,the frame elements may be used to provide additional scaffolding and/orradial strength.

The passive radial elements 18 illustrated in FIG. 3 comprise U-shapedmembers 34′ and 34″, which are inverted with respect to one another. Theapices of the inverted U-shaped members are connected to one another bya linkage element 36. The configurations of the passive radial elementsmay vary greatly depending on the desired stent attributes. For example,the inverted U-shaped members 34′ and 34″ and the linkage element 36 ofa passive radial element may be aligned within the module in a directionsubstantially parallel to the circumferential axis (as shown in FIGS.1-3). Alternatively, the inverted U-shaped members 34′ and 34″ and thelinkage element 36 of a passive radial element may be aligned within themodule in a direction which is diagonal to the circumferential axis (asshown for example in FIGS. 4-6). In other variations, the linkageelement 36 which connects the apices of inverted U-shaped members 34′and 34″ may be short (as shown in FIG. 3) or relatively much longer (asshown for example in FIGS. 6-7). The linkage element 36 may also beconfigured to enhance flexibility, e.g., in a serpentine orspring-shape. In some preferred embodiments, the passive radial elementsmay not include U-shaped members at all. Instead, a variety of passive,non-mechanism radial element configurations may be employed betweenslide-and-lock radial elements. Some examples are shown in FIGS. 13 and14.

In preferred embodiments, each module is formed from a single piece ofmaterial-thereby avoiding any welding or other connections betweenlongitudinally adjacent mechanism and non-mechanism radial elements.Alternatively, the slide-and-lock and passive radial elements within alongitudinal module may be attached to one another by a weldlessconnection, e.g., adhesive. Welded connections are also encompassedwithin the present disclosure. Further details of the stent constructionare provided below in the Sections entitled “Metal Stents,” “PolymericStents” and “Methods of Manufacturing and Assembling Polymeric Stents.”

FIG. 4 shows a longitudinal module 12 of a slide-and-lock stent orvascular prosthesis device in accordance with another preferredembodiment of the present invention. Modular device designs allow for awide variety of combinations of mechanism and non-mechanism modulecomponents. As can be seen generally from FIG. 4, there are alternatingmechanism and passive (or non-mechanism) radial elements, with onepassive radial element 18 disposed between each slide-and-lock radialelement 14 in the module 12; although other configurations can besubstituted with efficacy as needed or desired. Where N=the number ofradial elements in a module, then up to N-1 passive radial elements maybe employed. More preferably, a module has at least two slide-and-lockradial elements, wherein at least N−2 passive radial elements may beused. The passive radial elements in this embodiment have safety catchesor tabs 38 and slots 40, but the slots do not have any stops, teeth,catches or other lockout structures. Accordingly, as illustrated in FIG.5, when a safety tab 38 from one passive radial element is slidablyengaged in the slot 40 of a circumferentially adjacent passive radialelement, there is neither resistance to expansion during deployment norresistance to recoil; thus, the radial element is still referred to as apassive or non-mechanism radial element. However, when the safety tab 38engaged in the slot 40 slides during deployment (radial expansion) tothe end of the slot 40, it will prevent further expansion duringdeployment, thereby providing a safety mechanism against over-expansion.As discussed above, the passive radial elements can be designed toprovide a variety of features and characteristics, including, but notlimited to, providing enhanced flexibility such as with spring elements(discussed further below), deployment mechanism control elements(discussed further below), preferential side branch access locations orpoints, and device over-extension safety catches (as discussed withregard to the safety tabs 38 and slots 40 shown in FIGS. 4 and 5.

One important aspect of a slide-and-lock design is the sizing resolutionachievable during deployment, and the amount of recoil exhibited duringcompressive loading. The finer the mechanism of the design, the higherthe sizing resolution and the lower recoil exhibited. One embodiment ofthe slide-and-lock radial element that facilitates sizing resolution andrecoil resistance employs staggered non-symmetric lockout geometries.FIGS. 1-5 illustrate examples of such staggered non-symmetric lockoutgeometry, wherein the slots 22 have stops 24 arranged in a staggeredpattern, on both proximal 28 and distal 30 sides of the slot 22.

Actuating Slide-and-Lock Design

In an alternate embodiment, the slide-and-lock radial elements mayemploy different non-symmetric lockout geometry, wherein all of thestops 24 are located on only one side of the slot 22 (See e.g., FIGS. 6and 7). Of course, those skilled in the art will appreciate thatregardless of whether a staggered or one-sided stop configuration isemployed, one can vary the sizing resolution by varying the number ofstops and the distance between individual stops, such that as thedistance between stops becomes lesser, sizing resolution increases, andas the distance between stops becomes greater, sizing resolutiondecreases. With reference to FIG. 6, the slide-and-lock radial element14 has a tab 20, an actuating catch member 42, and a slot 22. All of thestops 24 are located on one side of the slot-on the proximal side 28 inthe illustrated embodiment. Positive return elements 44 are located onthe opposite side of the slot-on the distal side 30 in the illustratedembodiment. While the tab 20 substantially maintains travel within theradial axis, the catch member 42 is disposed along a flexible neck 46,such that as the tab 20 slides through slot 22, the interaction of thecatch member 42 with the stops 24 causes the neck 46 to deflect towardthe distal side 30. In the illustrated embodiment of FIG. 6, to furtheroptimize the performance of an actuating slide-and-lock mechanism, apositive return element 44 is included into the deployment mechanism toensure return of the deflected neck 46 and the catch member 42 to itsnon-actuated position. More particularly, during radial expansion, thecatch mechanism, including the tab 20 and catch member 42, is firstdeflected distally (actuated) by the lockout stop 24. Once the catchmember 42 has passed the stop 24, it can either elastically return toits natural position (discussed further below) or, as illustrated inFIG. 6, the positive return element 44 is employed to redirect the catchmechanism (tab 20 and catch member 42) to its natural, pre-actuatedposition within the slot 22, such that the catch member 42 catches,engages, or is otherwise prevented by its interaction with the lockoutstop 24, from moving backwards to a more collapsed state (recoil).

FIG. 7 shows a module 12 employing an actuating slide-and-lock radialelement 14, similar to that shown and described with reference to FIG.6. In the illustrated embodiment of FIG. 7, all of the stops 24 arelocated on the proximal side 28 of the slot 22, like the embodimentshown in FIG. 6; however, there are no positive return elements (44 inFIG. 6) located along the distal side 30 of the slot 22 in FIG. 7.Instead, in this embodiment, the catch mechanism is designed toelastically return to its natural pre-actuated position.

FIGS. 8 and 9 are planar partial views of an active lockout mechanism,wherein a deflectable element is actively positioned by anotherfeature/geometry of the design to engage the lockout mechanism. Herewith reference to FIGS. 8 and 9, the drawings show a partialslide-and-lock radial element 14, comprising a non-deflectable actuatingrail 48 (which is centrally disposed in the illustrated embodiment),having disposed thereon an actuator 50, a plurality of which are shownsymmetrically disposed along both proximal and distal surfaces of thecentral rail in the illustrated embodiment. Slidably engaged with theactuating rail 48 is a deflectable rail 52, comprising a deflectablecatch element 54; two catch elements 54 are shown symmetrically disposedalong the deflectable rail 52 in the illustrated embodiment. Theactuators 50 on the actuator rail 48 and deflectable catch elements 54on the deflectable rail 52 are configured so that as the deflectablerail 52 slides along the actuating rail 48, the actuators 50 cause thedeflectable catch elements 54 to deflect outward. This active lockoutmechanism also includes teeth or stops 24 (disposed along a frameelement 32 in the illustrated embodiment), which are adapted to engagethe deflectable catch elements 54 once actuated, thereby preventingradial recoil. FIG. 8 shows the radial element before sliding causesactuation of the active lockout mechanism. FIG. 9 shows the radialelement after actuation of the active lockout mechanism, wherein thedeflectable catch elements 54 are shown deflected outward by theactuators 50 and engaging the stops 24.

In variations to the illustrated embodiment, the actuators 50,deflectable catch elements 54, and stops 24, may be positioned on any ofthe components of the slide-and-lock radial element, as long as theactuators 50 are positioned to cause active deflection of the slidablyengaged deflectable catch elements 54, such that deflection results inengagement of the stops 24 and lockout (inhibition of radial recoil).

Deformable Slide-and-Lock Stent

FIGS. 10 and 11 are plan views of a slide-and-lock radial element inaccordance another embodiment of the present invention. Theslide-and-lock radial element 14 illustrated in FIG. 10 has a tab 20,slot 22, stops or teeth 24, and a frame element 32 similar to thoseshown in FIG. 3. However, the slide-and-lock radial element 14 alsocomprises a deformable region 60. In the illustrated embodiment, theproximal and distal portions of the frame element 32 as well as theproximal 28 and distal 30 portions of the slot wall are modified in thedeformable region 60 to allow expansion and/or contraction in the radialaxis through material deformation. Of course, those skilled in the artwill readily appreciate that a variety of material configurations,including for example, zig-zag, U-shaped, serpentine, waves, undulating,and angled, configurations, as well as changes in material cross-section(e.g., from a flat sheet to a bendable wire), can be employed so as toproduce regions of deformability. Lengthwise adjacent slide-and-lockand/or passive radial elements may be integral with, e.g., cut from samepiece of material, or attached by a weldless connection. In someembodiments, lengthwise adjacent radial elements may be welded together.

FIG. 10 shows the radial element 14 before deformation, wherein thedeformable region 60 exhibits a zig-zag configuration, and FIG. 11 showsthe same radial element 14 after deformation (radial expansion), whereinthe deformable region 60 is stretched out to yield a linearconfiguration. In the illustrated embodiment of FIGS. 10 and 11, theradial element 14 (and the stent comprising such radial element(s))includes a deformable geometry that is incorporated into the overallstent design. The deformable regions 60 of the stent are constructed toeither plastically or elastically deform during radial expansion. As thestent expands, these deformable regions can be used to achieveadditional device radial expansion or increase device safety.

In one embodiment, the deformable regions plastically deform uponexpansion. Advantageously, this allows for additional expansion orsizing of the stent. In another embodiment, the deformable regionselastically deform allowing for over pressurization of the stent duringimplantation and upon release of over pressurization, the stent returnsto its intended diameter. Advantageously, this may allow for higherpressurization to treat/crack difficult lesions, while avoidingexcessive vasculature injury that may occur with excessive pressuredilatations.

In yet another embodiment, the deformable regions can deform eitherplastically or elastically. Advantageously, this allows for an increasedfactor of safety as the stent reaches its maximum radial expansionlimit.

FIG. 12 is a partial view of another embodiment of a deformableslide-and-lock stent 10. The drawing show a longitudinal module 12 withslide-and-lock 14 and passive 18 radial elements. Lengthwise adjacentradial elements within the module 12 are preferably attached by aweldless connection, and more preferably formed form the same piece ofmaterial. This embodiment comprises a deflectable tab 21, which isconfigured to allow it to deflect inwardly as it passes by the stops 24in the slot 23 of a radially adjacent slide-and-lock radial element 14,but plastically returns to its prior form and alignment to preventrecoil.

Two Sided Lockout Features

Some embodiments utilize a two-sided lockout feature, that is, stops orteeth 24 on both sides of a slot 22 (see, for example, FIGS. 1-6). Thetwo-sided mechanism can be employed to increase device alignment andadditionally limit off center device travel. In modified embodiments, asingle-sided lockout mechanism may be utilized, that is, teeth 24 ononly one side of the slot 22, (see, for example, FIG. 7) as needed ordesired. In another modified embodiment, a two-sided mechanism can beemployed by placing stops or teeth 24 on both sides of a rib element(see, for example, FIGS. 8-9). In this embodiment, more than one safetycatch elements 54 may be employed to interact with-both sides of the ribelement.

Elements to Enhance Flexibility of Stent Device

Embodiments of the slide-and-lock device design can incorporate elementswhich enable device flexibility in both the collapsed and expandedstates. This is accomplished by providing flexible or spring elementsthat, for example, vary the geometry and location of the attachmentsbetween adjacent radial elements.

FIG. 4, for example, shows flexible or spring elements 34′ and 34″ inthe configuration of inverted diagonally aligned U-shaped members. Withreference to FIGS. 13-15, various alternative embodiments of flexibleelements are illustrated. FIG. 13 shows inverted U-shaped members 34′and 34″ similar to those illustrated in FIGS. 1-3; however, the passiveradial elements in FIG. 13 further comprise safety tabs 38 andnon-mechanism slots 40. As detailed above with reference to FIG. 4, theinclusion of safety tabs 38 and slots 40 without locking elements(teeth, stops or catches) may provide an additional safety againstover-expansion, may help to maintain slidable engagement of radiallyadjacent modules, and may also maintain controlled radial expansionwithin the radial axis. FIG. 14 shows a series of serpentine flexibleelements 62 aligned in the longitudinal axis, contiguous with andabutting a slide-and-lock mechanism (with tab 20 and slot 22) on theproximal side and a circumferential band 64 on the distal side. Theserpentine elements 62 may provide regions of enhanced flexibilitybetween active slide-and-lock radial elements. FIG. 15 shows linearflexible elements 66 disposed diagonally (e.g., at an angle between theradial and longitudinal axes) between slide-and-lock radial elements.Here, the slide-and-lock radial elements illustrate a variation to thetab and slot design shown for example in FIGS. 1-3. The central rail 68in FIG. 15 comprises proximal 70′ and distal 70″ rail members, each withoutward facing teeth 24, and an open slot 72 disposed between the railmembers. The central rail 68 is adapted to slidably engage the receivingslot 74 of a radially adjacent slide-and-lock radial element, anddeflect or bow inward into the open slot 72 as the receiving slot 74ratchets past the teeth 24.

Frangible Deployment Control Mechanism

FIGS. 16 and 17 are partial views of a slide-and-lock stent moduleincorporating a frangible deployment control mechanism. The drawingsshow partial modules with passive radial element 18 having a safety tab38 and a non-locking (toothless) slot 40, similar to those shown withreference to FIG. 4; however, the passive radial element in FIGS. 16 and17 include frangible members 80 that extend into the slot 40. Lengthwiseadjacent radial elements are preferably attached by a weldlessconnection, and more preferably formed from the same piece of material.FIG. 16 shows the passive radial element 18 before plastic deformationof the frangible members 80 and FIG. 17 shows the passive radial element18 after plastic deformation of the frangible members 80.

In the embodiment illustrated in FIGS. 16 and 17, the frangible(plastically deforming) members 80 serve as a deployment controlmechanism. The frangible members 80 act as a positive stop for aradially adjacent radial element having a safety tab slidably engagedwithin slot 40. During radial expansion, the slideably engaged radialelement plastically deforms the obstructing frangible members 80 out ofthe path of its safety tab. This feature provides a temporary stop whichallows other elements to fully expand before the temporary stop isovercome by additional radial expansion force. This feature isadvantageous in facilitating uniform deployment.

Tapered/Non-Uniform Geometries to Improve Profile and Flow

The embodiments illustrated in FIGS. 18-21 utilize cross-sectionalgeometrical shapes of the radial elements that are modified/optimized toreduce the turbulence of the blood in lumen flow and/or create generallydesirable blood flow characteristics. Stated differently, fluid flowprincipals are utilized to provide a strut or wall cross-section that isconducive to creating generally laminar and/or uniform flowcharacteristics.

FIG. 18 illustrates one embodiment of a streamlined strut configuration92 for creating generally laminar and/or uniform flow characteristicswhere the blood flow is generally in the direction indicated by arrow90. FIG. 19 illustrates another embodiment of a streamlined strutconfiguration 94 for creating generally laminar and/or uniform flowcharacteristics. The direction of blood flow is generally indicated byarrow 90.

FIG. 20 illustrates an embodiment of a strut configuration 96 thatutilizes a differential thickness beam, in either the axial orcircumferential direction. A differential geometry can be employed toprovide thickness and strength where needed or desired and allow forincreased flexibility and minimized step down as needed or desired. Thedirection of blood flow is generally indicated by arrow 90.

FIG. 21 illustrates an embodiment that utilizes the streamlining conceptto reduce step down effects between overlapping elements, such aselements 100 and 98. A tapered edge 102 allows the element 100 to blendinto the underlying element 98 thereby, and advantageously, creating asubstantially non-stepped transition point and eliminating any largestep differential between the elements 100 and 98.

In another advantageous feature, it will be appreciated that preferredembodiments of the present invention provide very efficient surfacecoverage, which is particularly advantageous when the stent is used witha therapeutic agent. More particularly, the slide-and-lock mechanism isconfigured such that virtually all the surface area of the lockingelements is in contact with the inner wall of the body lumen.Accordingly, the preferred embodiments allow for greater surfacecoverage as compared with existing stent configurations. When comparedwith other stent configurations, such as those utilizing deformablestruts, the surface coverage may be increased to as much as 25% to 70%without compromising stent performance or flexibility. Because the stentshape of various preferred embodiments provides excellent surfacecoverage, a larger amount of the therapeutic agent may be delivered tothe surrounding tissue. As a result, the agent may be used moreeffectively, thereby increasing the therapeutic effect. Alternatively,the therapeutic agent may be used in a lower concentration, therebyreducing local toxicity.

Solid Wall Stents and Grafts

With reference now to FIG. 22, another module or row 800 of radialelements 800A-800D is illustrated that may be used alone or incombination with similar elements to provide an expandable stentstructure. In many respects, the module or row 800 of radial elements800A-800D is similar to the modules described above (See e.g., FIGS.1-3). However, in this embodiment, the flexible body is formed with asolid wall 802 along a central portion of the row for providing enhancedsurface coverage in a desired region of a body lumen. In variations tothe embodiment illustrated in FIG. 22, the solid wall 802 may bedisposed anywhere along the longitudinal length of the module or row.Moreover, in some embodiments it may be preferred to employ more thanone solid wall along the length of the module. These solid wall regionsmay-be adjacent to one another or separated.

More particularly, the solid wall 802 is preferably fabricated from animpermeable material and is configured to provide substantially completecoverage along a portion of a body lumen. In preferred embodiments, thesolid wall 802 extends along the longitudinal axis at least 2millimeters. Accordingly, this embodiment is particularly well suitedfor placement along a vascular anomaly, such as a vascular aneurysm, forsupporting or sealing off a particular region along a vessel.

In the illustrated embodiment, each radial element 800A-800D comprises alocking tab 812 that interacts with teeth along deflectable rails forproviding a locking mechanism. In some embodiments, e.g., where thestent is fabricated from a shape-memory material (e.g., Nitinol), eachradial element 800A-800D may include a hold-down tab 850 sized to bereleasably held within a recess for providing a hold down mechanism. Itshould be appreciated that a wide variety of locking mechanisms andhold-down mechanisms may be used (See e.g., those detailed in co-pendingU.S. application Ser. No. 10/897,235; the entire disclosure of which isincorporated herein by reference), and that the illustrated embodimentis merely for the purpose of description. Flexible coupling members832A, 832B may be provided between individual elements to provideenhanced flexibility. In one preferred embodiment, the module or row 800of elements is fabricated from a shape memory material to providecrush-recoverability. During use, the radial elements comprising themodule or row 800 are preferably slidably interconnected with othersimilar radial elements in circumferentially adjactent modules or rowsto provide a balloon expandable stent. However, in an alternativeconfiguration, the element 800 of FIG. 22 may be wrapped onto itself toprovide an expandable stent.

With reference now to FIG. 23, an alternative row 860 is illustratedwhich further comprises an opening 870 (e.g., a circular hole) formed inthe wall portion 862. The opening is preferably provided for allowingfluid communication through the wall 862. Accordingly, this variation860 is particularly well suited for treating a lesion along a vesselbifurcation. The row 860 may be interconnected with one or more rows 800of the type described above with respect to FIG. 22 to provide anexpandable stent having a solid central portion formed with an opening.When deployed, the stent may be advantageously used to ensure thepatency of a main vessel while allowing blood to flow into or out of abranch vessel. In yet other variations, the wall may be permeable or afilter may be provided along the opening 870 for preventing emboli orother debris from passing through the opening.

Of course, it will be appreciated that deflectable teeth may be used inthose embodiments shown in FIGS. 22-23, rather than deflectable rails ormembers (as shown), to provide the stent with mono-directionalexpansion. A detailed description of deflectable teeth and accompanyingillustrations are provided below with reference to FIGS. 25-27.

In yet another variation, stent embodiments configured in accordancewith the present invention may also be useful in vessel grafts, whereinthe stent is covered with a sheath formed at least in part from either apolymeric material, such as expanded PTFE, or a natural material, suchas fibrin. One variation of a graft in accordance with the presentinvention is illustrated in FIG. 24. The tubular graft comprises anexpandable stent 10 of the type described herein with reference to FIGS.1-23 and 25-35 and a polymeric sheath 900. Because of the low profile,small collapsed diameter and great flexibility, stents made inaccordance with this embodiment may be able to navigate small ortorturous paths. Thus, this variation may be useful in coronaryarteries, carotid arteries, vascular aneurysms (when covered with asheath), renal arteries, peripheral (iliac, femoral, popliteal,subclavian) arteries. Other nonvascular applications includegastrointestinal, duodenum, biliary ducts, esophagus, urethra, trachealand bronchial ducts.

Deflectable Teeth Lockout Mechanisms

In yet another alternative embodiment, it will be appreciated thatdeflectable teeth may be used, rather than deflectable rails or members,to provide the locking mechanism that facilitates mono-directionalexpansion. For example, FIG. 25 illustrates a portion of another stentembodiment 300 wherein two radial elements 300(1), 300(2) are slidablyinterconnected. Each radial element is provided with a rail 308 having aplurality of deflectable teeth 306. Similar radial elements may becoupled via flexible linkage elements 310, 312 to provide a stent havinga desired axial length. In this embodiment, the engagement meanscomprise locking tabs 302, 304 which are configured to slidecircumferentially within elongate slots surrounding the rail, and toslide along the sides of the deflectable teeth 306. Each of the teeth issufficiently flexible such that the teeth may deform inward toward therail 308 (i.e., within the plane of the radial element) for allowing thelocking tabs 302, 304 to pass in one direction. However, due to theangle of the teeth, the locking tabs are prevented from moving in theother direction, thereby providing yet another preferred mechanism formaintaining the stent in the expanded condition after deployment.

With reference now to FIG. 26, a portion of another preferred stentembodiment 320 is illustrated wherein radial elements 320(1), 320(2) areslidably interconnected. Similar to the embodiment just described, eachradial element is provided with a rail 328 having a plurality ofdeflectable teeth 326. However, in this embodiment, each of the teeth isangled upward and is configured to deflect downward (i.e., in a radialdirection), rather than inward toward the rail as discussed with respectto FIG. 25. As the locking tabs 322, 324 slide along the deflectableteeth 326, the teeth are caused to deflect downward for allowing thetabs 322, 324 to pass over the teeth 326 during deployment. However, dueto the angle of the teeth, the locking tabs may only move in onedirection. More particularly, if a compressive force pushes the radialelements 320(1), 320(2) back toward the collapsed condition, the lockingtabs 322, 324 will abut against the teeth 326, thereby preventingfurther relative movement. For additional reference, FIG. 27 illustratesradial element 320(1) in isolation. Flexible linkage elements 330, 332allow multiple radial elements to be joined to form a row.

With reference to FIGS. 28A-C, another embodiment of the slide-and-lockstent is illustrated, wherein the locking mechanism comprisesdeflectable teeth disposed on rails similar to those shown in FIGS.25-27; however, after assembly, a rail is slidably engaged withinengagement means comprising a closed loop which defines a slot. FIG. 28Ashows a plan view of such a module 1100 comprising three radial elements1102. Each radial element comprises a rail 1104 comprising a pluralityof deflectable teeth 1106, and a closed loop 1108, which forms a slot1110 configured to slidably engage a rail 1104 from a circumferentiallyadjacent radial element 1102 in a circumferentially adjacent module orrow 1100. The slot 1110 is also configured to accept the loop 1108 andrail 1104 from the adjacent radial element during assembly, such thatcircumferentially adjacent modules can be slidably interlocked withoutwelding or bonding of any sort required. In the illustrated embodiment,the longitudinally adjacent radial elements 1102 are connected to oneanother via flexible linkage elements 1112. Of course, any linkageconfiguration may be substituted without departing from the inventiveelements of this embodiment. The illustrated rails 1104 have a centralgap 1114 that may be configured to provide more or less deflection ofthe teeth 1106 as they pass through the slot 1110 during expansion. Oneor more bridges 1116 may connect the two sides of the divided rail.Generally, the more bridges the less deflection the rail may offer.

FIG. 28B shows the same module 1100 illustrated in FIG. 28A, except ithas been bowed to show how the module comprises a portion of thecircumference of a stent assembled from 2 or more such modules.

FIG. 28C illustrates a partial stent comprising two modules 1100′ and1100″ like those showin in FIGS. 28A and 28B. It will be appreciatedthat the rail 1104″ from module 1100″ is slidably engaged in the slot1110′ formed in closed loop 1108′ from module 1100′.

A variation to the deflectable tooth slide-and-lock module shown inFIGS. 28A-C is illustrated in FIG. 29, wherein the longitudinallyadjacent radial elements 1102 are circumferentially offset by angledlinkage elements 1122.

Deflectable Teeth Lockout Mechanisms Having Tapered Thicknesses

Referring now to FIGS. 30A-C, another embodiment of the slide-and-lockstent is illustrated. The innovative embodiments illustrated in FIGS.30A-C are similar to FIGS. 25-29, wherein the locking mechanismcomprises deflectable teeth disposed on rails, and particularly similarto FIGS. 28A-29, wherein after assembly, a-rail is slidably engagedwithin engagement means comprising a closed loop which defines a slot.However, the embodiments shown in FIGS. 30A-C further provide that theradial elements of the stent are uniquely configured to include taperedsections in the circumferential direction in order to reduce the radialthickness of the stent at the overlapping sections of circumferentiallyadjacent modules. Such an embodiment may also provide a reducedcross-sectional profile compared to other stents that do not have radialelements with such tapered sections. Furthermore, it is alsocontemplated that the radial elements may be configured to provide anapproximately constant radial thickness of the stent despite overlap ofcircumferentially adjacent radial elements.

FIG. 30A shows a perspective view of such a module 1200 comprising tworadial elements 1202, as similarly illustrated in FIG. 28A. Each radialelement 1202 comprises a rail 1204 comprising a plurality of deflectableteeth 1206, and a closed loop 1208, which forms a slot 1210 configuredto slidably engage a rail 1204 from a circumferentially adjacent radialelement 1202 in a circumferentially adjacent module or row 1200. Theslot 1210 is also configured to accept the loop 1208 and rail 1204 fromthe adjacent radial element during assembly, such that circumferentiallyadjacent modules can be slidably interlocked. In such an embodiment,welding or bonding of may be required to properly adjoin adjacentmodules. In the illustrated embodiment, the longitudinally adjacentradial elements 1202 are connected to one another via flexible linkageelements 1212. The flexible linkage elements 1212 may be similarlyconfigured to other as described herein. Of course, various linkageconfigurations may be substituted without departing from the inventiveelements of this embodiment. The illustrated rails 1204 may have acentral gap 1214 that may be configured to provide more or lessdeflection of the teeth 1206 as they pass through the slot 1210 duringexpansion. One or more bridges 1216 may connect the two sides of thedivided rail. Generally, the more bridges the less deflection the railmay offer.

According to the unique aspect of the invention mentioned above and asillustrated in the embodiment of FIG. 30A-C, a plurality of modules maybe uniquely configured to include radial elements with tapered sectionsin order to reduce the radial thickness of the stent at the overlappingsections of circumferentially adjacent radial elements. Stents withnon-tapered radial elements have a “double radial thickness” where themodules circumferentially interlock and overlap. According to anembodiment of the present invention, in order to overcome the “doubleradial thickness” deficiency, each radial element may be formed toinclude tapered sections that nest within respective tapered sections toreduce the cross-sectional profile of the stent.

For example, as illustrated in FIG. 30A, the thickness of the loop 1208of the radial element 1202 may taper in the circumferential directionapproaching a distal edge 1218 of the loop 1208. Similarly, thethickness of the rail 1204 of the radial element 1202 may also taper inthe circumferential direction approaching a distal edge 1220 of an upperportion 1222 of the rail 1204. Finally, the thickness of the rail 1204of the radial element 1202 may also taper in the circumferentialdirection approaching a distal edge 1224 of a lower portion 1226 of therail 1204. Therefore, when the stent is expanded, as illustrated in FIG.30C, these tapered sections of the loop 1208 and the upper and lowerportions 1222, 1226 of the rail 1204 may nest with respective taperedsections to reduce the cross-sectional profile of the stent.

In an illustration of the nesting of the tapered sections, shown inFIGS. 30B-C, the stent may comprise modules 1200′, 1200″, and 1200′″which combine to form the tubular member of the stent. In thisembodiment, the loop 1208″ of the radial element 1202″ of the module1200″ engages the respective rail 1204′ from the adjacent radial element1200′ to facilitate slidable interlocking of adjacent modules 1200″ and1200′, the loop 1208′″ of the radial element 1202′″ of the module 1200′″engages the respective rail 1204″ from the adjacent radial element 1200″to facilitate slidable interlocking of adjacent modules 1200′″ and1200″, and the loop 1208′ of the radial element 1202′ of the module1200′ engages the respective rail 1204′″ from the adjacent radialelement 1200′″ to facilitate slidable interlocking of adjacent modules1200′ and 1200′″. As illustrated, the modules 1200′, 1200″, 1200′″ caneach include distal edges 1220′, 1220″, 1220′″, respectively. As shownin FIG. 30C, when the stent is expanded, the tapered section of the loop1208″ and the tapered section of the upper portion 1222″ of the module1200″ nest with the tapered section of the lower portion 1226′ of themodule 1200′ , the tapered section of the loop 1208′ and the taperedsection of the upper portion 1222′ of the module 1200′ nest with thetapered section of the lower portion 1226′″ of the module 1200′″, andthe tapered section of the loop 1208′″ and the tapered section of theupper portion 1222′″ of the module 1200′″ nest with the tapered sectionof the lower portion 1226″ of the module 1200″.

Referring still to FIG. 30C, the radial thickness of the expanded stentmay be a maximum of approximately 1½ of the thickness of the non-taperedportion of the rail 1204. For example, as shown in FIGS. 30A and 30C,the maximum thickness of the loop 1208 may be approximately 1½ of thethickness of the non-tapered portion of the rail 1204. As shown, theloop 1208 then tapers from this maximum thickness toward a thickness of½ of the thickness of the non-tapered portion of the rail 1204 in thecircumferential direction approaching the distal edge 1218 of the loop1208. However, the maximum combined radial thickness is preferably alsoapproximately 1½ of the thickness of the non-tapered portion of the rail1204. The combined radial thickness may be measured such as at thedistal edge 1218 of the loop 1208 and at the distal edge 1220 of therail 1204. Thus, at the distal edge 1218 of the loop 1208, where theloop 1208 nests with the non-tapered portion of the rail 1204, thecombined thickness of the loop 1208 and the rail 1204 will be 1½ of thethickness of the non-tapered portion of the rail 1204 (the loop 1208being ½ of the thickness of the rail 1204 at this intersection). Insummary, the thickness of the radial element 1202 along the non-taperedportion of the rail 1204 may be a first thickness, and the taperedsections of the module 1200 may taper toward approximately a secondthickness. The second thickness is preferably approximately one-half ofthe first thickness. For example, the first thickness (the thickness ofthe non-tapered portion) may be approximately 0.0040 inches, and thesecond thickness may be approximately 0.0020 inches. Accordingly, themaximum combined radial thickness of the first and second thicknesses inthe overlapping sections of the stent preferably does not exceed 1½ ofthe thickness of the non-tapered portion of the rail 1204. However, itis contemplated that the first thickness may vary by as much as 0.0010inches, or that the second thickness may vary by as much as 0.0005inches. In this regard, the second thickness may sometimes be greaterthan ½ of the first thickness, thus resulting in a combined thickness ofslightly greater than 1½ of the first thickness. Other variations due tomanufacturing variations may result; however, the general teachingsherein may nevertheless be utilized to provide for a stent with areduced cross-sectional profile relative to stents without taperedradial elements.

Therefore, the individual thicknesses of the respective ones of the rail1204, the loop 1208, and the upper portion 1222 of the rail 1204 maygradually taper corresponding to the thicknesses of the respective onesof the rail 1204, the loop 1208, and the upper portion 1222 of the rail1204, with which it is nested, in order to ensure that the maximumcombined thickness in the overlapping sections does not exceed 1½ of thethickness in the non-tapered portion of the rail 1204.

Such an embodiment may also provide a reduced cross-sectional profilecompared to other stents that do not have modules with such taperedsections. The tapered sections provide the stent with an increasedinterior diameter and a decreased exterior diameter. For example, if thetapered stent includes overlapping sections that measure approximately0.0060 inches (as opposed to 0.0080 inches on a non-tapered stent, asdiscussed above), then the exterior diameter of the stent may be reducedby at least 0.0020 inches at at least two or three overlapping sections(see FIG. 30C), and perhaps 0.0040 inches, depending on theconfiguration of the deployed stent. Furthermore, the interior diameterof the stent may likewise increase due to two considerations. First, asillustrated in FIG. 30C, the interior diameter of the module may beincreased by 0.0020 inches at at least two or three overlappingsections, and as much as 0.0040 inches relative to non-tapered stents,depending on the configuration. Second, it is contemplated that thedecrease in the exterior diameter may allow the stent to be furtherexpanded, thus further increasing the interior diameter of the taperedstent relative to a non-tapered stent. As a result, the deployed taperedstent may provide better flow characteristics (such as tending to ensurelaminar flow of the blood within the stent due to tapered interiorgeometries), as well as increased blood flow rate due to the eliminationof a portion of the radial thickness of the stent. Indeed, by includingthe tapered sections along the module 1200, the inside diameter of thestent may be increased in the two ways mentioned above, withoutrequiring a larger exterior diameter than the non-tapered stent. Thus,the stent may be more efficient that previous non-tapered stents.

In addition, the exterior of the stent may be smooth (i.e. lower surfaceroughness than stents with non-tapered modules) due to the decreasedthickness of both the lower portion 1226 of the rail 1204 and the loop1208, which are typically disposed on the exterior of the stent, asshown in FIGS. 30B-C. The reduced cross-sectional profile also allowsthe exterior of the stent to more fully contact the interior walls ofthe body lumen. Therefore, the insertion and/or removal of the stent maybe facilitated by the inclusion of the tapered areas.

In accordance with another advantageous aspect of the present invention,the addition of the tapered sections may also provide for a reducedcross sectional profile when the stent is in its “crimped down”undeployed state. As discussed above, the exterior diameter of thedeployed stent may be decreased by as much as a single thickness of thenon-tapered portion of the rail 1204. However, an even more dramaticreduction is possible in the size of the undeployed stent. Through theuse of tapered sections, the outside diameter of the undeployed stentmay be reduced in the order of 0.0040 to 0.0120 inches (1 to 3 times thethickness of the non-tapered rail 1204). For example, the modules 1202of the stent curl inwardly multiple times when in bundled (i.e.undeployed) state. In this state, the tapered sections of the module areup to 0.0020 inches thinner than a non-tapered portion. Thus, each layerof a tapered section represents a decrease of 0.0020 inches in theoutside diameter of the bundled (i.e. undeployed) stent. Decreases ofbetween 0.004 and 0.0120 inches are thus possible when compared tonon-tapered stents. Thus, the tapered sections of the stent may alsogreatly facilitate insertion of the undeployed stent due to the reducedcross-sectional profile of the undeployed stent.

Furthermore, it is also contemplated that the modules may be configuredto provide an approximately constant radial thickness of the stentdespite overlap of circumferentially adjacent modules. Thus, therespective thicknesses of the respective ones of the rail 1204, the loop1208, and the upper portion 1222 of the rail 1204 may gradually tapercorresponding to the thicknesses of the respective ones of the rail1204, the loop 1208, and the upper portion 1222 of the rail 1204, withwhich it is nested, in order to ensure that the maximum combinedthickness in the overlapping sections does not exceed the thickness inthe non-tapered portion of the rail 1204. Such a configuration may tendto improve the cross-sectional profile of the stent by maximizing theinterior area of the stent while maintaining or even reducing theexterior profile (i.e. exterior area) of the stent. This improvement maythus result in improved flow rate relative to stents having non-taperedmodules.

Serrated Surface Lockout Mechanisms

With reference now to FIG. 31, a portion of another stent embodiment 340is illustrated wherein radial elements 340(1), 340(2) are slidablyinterconnected. Each radial element is provided with an outer surfaceformed, at least in part, with a series of serrations or ridges. Moreparticularly, the surfaces comprise a series of valleys 344 and ridges346. In the illustrated configuration, a locking tab 342 of radialelement 340(2) slides along the surface of radial element 340(1). Thelocking tab 342 is formed with a thin neck portion 350 and a wider headportion 352. The neck portion 350 is configured for allowing the head352 to deflect outward in a radial direction. The shape of the valleys344 and ridges 346 allows the head 352 of the locking tab 342 to ratchetalong the surface of the adjacent element in only one direction, therebyproviding a locking means to maintain the stent in the expandedcondition. Although the ridges and valleys are only necessary along theregion wherein the locking tab slides, each of the radial elements maybe formed with a continuous contoured surface for ease in manufacturing.In one variation, the shaped bottom surface of the first element 340(1)may slide along the top surface of the shaped second element 340(2) forproviding the desired ratcheting effect. In this variation, the tab 342may be used primarily for interconnecting the elements in a slidableconfiguration.

Variations in Lockout Mechanisms and Circumferentially Offset RadialElements

With reference now to FIG. 32, another alternative module or row 400 ofradial elements 400A-400E is illustrated. In this embodiment, theindividual radial elements in a module or row are coupled in astaggered, circumferentially offset arrangement by a series of flexiblecoupling elements 420. In preferred embodiments, the illustrated moduleor row 400 may be slidably interconnected with other similar,circumferentially adjacent modules to provide a stent. Each of theradial elements is substantially identical and includes a locking tab402 having a neck portion 410. Each of the radial elements furtherincludes a containment gap 408 for holding an adjacent locking tab and aseries of opposing teeth 406 along the containment gap for providing amono-directional expansion.

With reference now to FIGS. 33A and 33B, the slide-and-lock relationshipbetween interconnected radial elements of the type shown in FIG. 32 isillustrated. FIG. 33A shows the radial elements 400A(1), 400A(2) in acollapsed configuration wherein the locking tab 402 of radial element400A(2) is held within the containment gap 408 of radial element400A(1). The body of radial element 400A(2) extends through a slot 404formed in radial element 400A(1) for maintaining the elements in thedesired slidable relationship. FIG. 33B shows the radial elements400A(l), 400A(2) in an expanded condition. As shown in FIG. 33B, thelocking tab 402 of 400A(2) is disposed in the gap 416 betweendeflectable members 412, 414 of 400A(1) and is locked in place by teeth406.

In one advantageous feature, a stent comprising the sliding and lockingrows illustrated in FIGS. 32 through 33B provides improved uniformity insurface coverage due to the staggered relationship of the individualradial elements. Furthermore, the stent is capable of providing adequatesupport to the body lumen while minimizing the total area of surfacecoverage. This is a particularly advantageous feature since a largepercentage of the natural inner surface of the body lumen remainsexposed after stent deployment. In another advantageous feature, eachradial element passes through the slot 404 of the adjacent radialelement for securely maintaining the components in a slidablyinterlocked condition. Still further, this stent embodiment providesexcellent flexibility after deployment.

As discussed above, it will be appreciated by those skilled in the artthat stents constructed according to the present invention may comprisea wide variety of other slide-and-lock elements while still providingthe features and advantages described herein. The slide-and-lockelements illustrated and described above are merely preferredembodiments and alternative slide-and-lock elements may be employedwithout departing from the scope of the invention. For example, avariety of alternative one-way locking mechanisms, which may be used tofacilitate mono-directional stent expansion, can be found in Applicant'sco-owned U.S. Pat. Nos. 6,033,436, 6,224,626 and 6,623,521, each ofwhich is incorporated by reference herein.

With reference now to FIG. 34, yet another preferred embodiment of astent 500 comprises alternative slide-and-lock mechanisms which areinterconnected to provide a tubular member sized for deployment in abody lumen. In the illustrated embodiment, a plurality of interconnectedrows 500A-500D is provided wherein each row preferably extends along theentire axial length of the stent 500. This stent configurationadvantageously combines excellent longitudinal flexibility (i.e.,bending) with a very high radial strength. Although the stent 500 shownin FIG. 34 is illustrated with four interconnected rows 500A-500D, thenumber and length of the rows may vary to meet the particularrequirements of the application.

With reference now to FIG. 34A, a single row 500A comprises a structureshaped for providing the stent with excellent flexibility along thelongitudinal axis. This feature allows the stent to bend during deliveryand to more easily conform to the shape of a body lumen afterdeployment. Furthermore, this embodiment eliminates the need forflexible linkage elements. The row 500A illustrated in FIG. 34A includesa series of peaks 502 and valleys 504 wherein each peak is provided witha protrusion 506 and each valley is provided with a slot (e.g., see 510of FIG. 34) shaped for receiving an adjacent protrusion. Of course, notall peaks and valleys necessarily comprise protrusions or slots. Asillustrated, each of the protrusions 506 is preferably provided with twoparallel deflectable members 514 formed with a number of teeth 508. Eachof the teeth 508 is formed with an angled side and a flat side.Furthermore, each of the protrusions 506 is formed with a gap 512extending between the deflectable members 514.

When assembled, the protrusions 506 are slidably received within theslots 510 as illustrated in FIG. 34. The interaction between the angledteeth 508 and slots 510 is preferably configured to provide a stent 500exhibiting mono-directional expansion. In particular, during expansion,the interaction between the teeth 508 and the slot 510 causes thedeflectable members 514 to flex inward for allowing the teeth to passthrough the slot 510. The deflectable members 514 are caused to flexinward because the edges of the slot act on the angled side of theteeth. However, when a force is applied in the other direction, the flatsides of the teeth abut against the edges of the slot and no inwardforce is produced. Accordingly, the teeth 508 are prevented from slidingback out of the slots 510, thereby maintaining the stent in the expandedcondition after deployment at a treatment site.

In preferred embodiments, the force required to move the protrusionsthrough the slots is large enough such that the stent will notinadvertently expand during delivery to the treatment site. Therefore,the stent is held down in the collapsed condition before deployment. Ifnecessary, the assembly may be constructed such that the initialresistance produced by the first set of teeth on each protrusion isgreater to ensure that the stent remains in the collapsed conditionduring delivery.

In an advantageous feature, each of the mating protrusions and slots maymove (i.e., ratchet) independently of the others. Accordingly, inaddition to providing excellent flexibility, the diameter of the stentmay vary along the longitudinal axis for precisely conforming to theinner diameter of the vessel. In still another advantage, theprotrusions are received within slots formed in the adjacent row.Therefore, the slide and lock mechanism maintains a very low profileafter deployment. Indeed, in accordance with preferred embodiments, themodules comprising serpentine peaks 502 and valleys 504 may befabricated from three or more layers of material (two outer layers andone or more inner layers), such that the slots 510 are defined by theouter layers, with a gap where at least one region of inner layers ismissing, whereas the protrusions 506 are formed from the correspondinginner layer(s), with missing outer layers. Thus, as the protrusionsarticulate within the slots, there is no overlap of any stent elements.The thickness of the slidable articulation (between protrusions andslots) is substantially the same as the thickness of the rest of thestent.

With reference now to FIG. 35, stent 550 comprises yet anotherconfiguration of slide-and-lock elements which are interconnected toprovide a tubular member sized for deployment in a body lumen. Similarto the stent described above with respect to FIG. 34, in thisembodiment, a plurality of interconnected rows 550A-550D is providedwherein each row preferably extends along the entire axial length of thestent 550. Although the stent 550 shown in FIG. 35 is illustrated withfour interconnected rows 550A-550D, the number and length of the rowsmay vary to meet the particular requirements of the application.

With reference now to FIG. 35A, a single row 550A comprises a structureshaped for providing the stent with excellent flexibility. This featureallows the stent to bend during delivery and to more easily conform tothe shape of a body lumen after deployment. The row illustrated in FIG.35A includes a series of peaks 552 and valleys 554 wherein each peak isprovided with a protrusion 556 and each valley is provided with a slotextending therethrough. Each of the protrusions 556 is preferablyprovided with two deflectable members 564 formed with a number of teeth558. Each of the teeth 558 is formed with an angled side and a flatside. Furthermore, each of the protrusions 556 is formed with a gap 562extending between the deflectable members 564. When assembled, theprotrusions 556 are slidably received within the slots 560 asillustrated in FIG. 35. The interaction between the angled teeth 558 andslots 560 is preferably configured to provide a stent 550 exhibitingmono-directional expansion. In particular, during expansion, theinteraction between the teeth 558 and the slot 560 causes thedeflectable members 564 to flex inward for allowing the teeth to passthrough the slot 560. The deflectable members 564 are caused to flexinward because the sides of the gap act on the angled side of the teeth.However, when a force is applied in the opposite direction, the flatsides of the teeth abut against the sides of the gap and no inward forceis produced. Accordingly, the teeth 558 are prevented from sliding backout of the slots 560, thereby maintaining the stent in the expandedcondition after deployment at a treatment site.

With reference again to the embodiment illustrated in FIG. 35, theprotrusions preferably pass in a radial direction through the gaps inthe adjacent rows. After deployment, an end portion of each protrusionmay protrude radially outward from the tubular member, as shown in FIG.35. The end portions may advantageously provide an anchoring mechanismfor further securing the stent 550 at the treatment site afterdeployment. In another advantageous feature, the stent embodiment 550illustrated in FIG. 35 may be constructed in an inexpensive manner andprovides a modular design that may be combined in a variety of differentways to provide an expandable stent suited for a particular purpose.

FIGS. 36A-C illustrate yet another alternative embodiment of the presentinvention wherein an expandable stent is formed from a single element700. The single element 700 may function in a manner similar to certainembodiments described above. More particularly, the element 700 includesa locking tab 740 having a wide head portion 744 and a thin neck portion742. In embodiments where the stent is fabricated from a shape-memorymaterial (e.g., Nitinol), the stent may optionally include a hold-downtab 750 having a wide head portion 754 and a thin neck portion 752.Still further, the stent includes first and second deflectable members760, 762 formed with teeth 766 along an inner edge. The element 700 alsoincludes first and second containment members 780, 782 disposed inparallel to the deflectable members. As illustrated in FIG. 36B, thesingle radial element is rolled onto itself to provide a tubular memberwith the head portion 742 of the locking tab 740 extending through a gap764 between the deflectable members 760, 762. When in the collapsedcondition, as shown in FIG. 36B, the optional hold-down tab 750 is heldwithin recesses (see element 788 of FIG. 36A) that prevents the stentfrom expanding during delivery to a treatment site. However, duringdelivery, the optional hold-down tab 750 may be released from therecesses 788 and the diameter of the radial element expands. Duringexpansion, the locking tab 740 passes through the teeth 766 along thedeflectable members 760, 762 until the stent is expanded to the desireddiameter, as shown in FIG. 36C. The configurations of the teeth preventthe locking tab 740 from moving back, thereby ensuring that the stent isheld in the expanded condition. In an advantageous feature, thisembodiment, which has a “jelly-roll” configuration, does not involve anyinterconnected components and therefore benefits from simplicity inconstruction. Accordingly, during use, this embodiment providesexcellent reliability and structural integrity.

Although a stent formed from a single integral element is describedabove as having particular mechanical characteristics for locking thestent in the expanded condition, a variety of other “slide-and-lock”mechanisms may be used without departing from the scope of theinvention. For example, other suitable locking mechanism may be found inU.S. Pat. No. 5,344,426 to Lau, U.S. Pat. Nos. 5,735,872 and 5,876,419to Carpenter, U.S. Pat. No. 5,741,293 to Wijay, U.S. Pat. No. 5,984,963to Ryan, U.S. Pat. Nos. 5,441,515 and 5,618,299 by Khosravi, U.S. Pat.No. 5,306,286 to Stack, U.S. Pat. No. 5,443,500 to Sigwart, U.S. Pat.No. 5,449,382 to Dayton, U.S. Pat. No. 6,409,752 to Boatman, and thelike. Each of these references is incorporated by reference herein. Inaddition, many of the slide-and-lock mechanisms disclosed in the abovepatents may be suitable for use with stents embodiments comprisingslidable interconnected elements of the type described above.

Although certain preferred embodiments are described above as providingmono-directional expansion during stent deployment, it will beappreciated that, in another mode of the present invention, the teeth orother engaging elements may be shaped and positioned to allowbi-directional movement (i.e., both expansion and contraction). Moreparticularly, the teeth may be constructed to allow for two-way movementbetween adjacent radial elements, such that the stent diameter may becollapsed after deployment. The teeth create a barrier that resists thestent from expanding or reducing in diameter. However, the resistancecreated by the teeth may be overcome during placement of the stent on aballoon and during deployment in the vessel. Preferably, the amount ofresistance created by the teeth is selected such that the stent diameterwill not reduce due to external pressures after deployment in thevessel. However, the teeth do not provide a locking mechanism thatlimits stent movement to mono-directional expansion. Accordingly, thediameter of the stent may be reduced for placement on an expandablemember. This feature provides a constraining or “hold-down” mechanismthat allows the stent to be placed on expandable member and alsoprevents the stent from expanding prematurely. This embodimentadvantageously obviates the need for deformable tabs, pins, crimpingmechanisms or other hold-down mechanisms.

Metal Stents and Methods of Manufacturing

Preferred materials for making the stents in accordance with someembodiments of the invention include cobalt chrome, 316 stainless steel,tantalum, titanium, tungsten, gold, platinum, iridium, rhodium andalloys thereof or pyrolytic carbon. In still other alternativeembodiments, the stents may be formed of a corrodible material, forinstance, a magnesium alloy. Although preferred stent embodiments havebeen described as being conventional balloon expandable stents, thoseskilled in the art will appreciate that stent constructions according tothe present invention may also be formed from a variety of othermaterials to make a stent crush-recoverable. For example, in alternativeembodiments, such as self expandable stents, shape memory alloys thatallow for such as Nitinol and Elastinite® may be used in accordance withembodiments of the invention.

Preferably, sheets are work-hardened prior to forming of the individualstent elements to increase strength. Methods of work hardening are wellknown in the art. Sheets are rolled under tension, annealed under heatand then re-worked. This may be continued until the desired modulus ofhardness is obtained. Most stents in commercial use today employ 0% to10% work hardened material in order to allow for “softer” material todeform to a larger diameter. In contrast, because expansion of thesliding and locking radial elements in accordance with embodiments ofthe invention depends on sliding rather than material deformation, it ispreferred to use harder materials, preferably in the range of about25-95% work hardened material to allow for thinner stent thickness. Morepreferably, the stent materials are 50-90% work hardened and mostpreferably, the materials are 80-85% work hardened.

Preferred methods of forming the individual elements from the metalsheets may be laser cutting, laser ablation, die-cutting, chemicaletching, plasma etching and stamping and water jet cutting of eithertube or flat sheet material or other methods known in the art which arecapable of producing high-resolution components. The method ofmanufacture, in some embodiments, depends on the material used to formthe stent. Chemical etching provides high-resolution components atrelatively low price, particularly in comparison to high cost ofcompetitive product laser cutting. Some methods allow for differentfront and back etch artwork, which could result in chamfered edges,which may be desirable to help improve engagements of lockouts. Furtherone may use plasma etching or other methods known in the art which arecapable of producing high-resolution and polished components. Thecurrent invention is not limited to the means by which stent or stentelements can be fabricated.

Once the base geometry is achieved, the elements can be assemblednumerous ways. Tack-welding, adhesives, mechanical attachment(snap-together and/or weave together), and other art-recognized methodsof attachment, may be used to fasten the individual elements. Somemethods allow for different front and back etch artwork, which couldresult in chamfered edges, which may be desirable to help improveengagements of lockouts. In one preferred method of manufacture, thecomponents of the stent may be heat set at various desired curvatures.For example, the stent may be set to have a diameter equal to that ofthe deflated balloon, as deployed, at a maximum diameter, or greaterthan the maximum diameter. In yet another example, elements can beelectropolished and then assembled, or electropolished, coated, and thenassembled, or assembled and then electropolished.

In another embodiment, in particular with shape memory alloys, the stentis heat set at beyond the maximum diameter then built mid diameter thanplaced over catheter and reverse ratcheted and locked into smallerdiameter and onto catheter with positive catch hold down mechanism toachieve a small profile and excellent retention.

Polymeric Stents

While metal stents possess certain desirable characteristics, the usefullifespan of a stent is estimated to be in the range of about 6 to 9months, the time at which in-stent restenosis stabilizes and healingplateaus. In contrast to a metal stent, a bioresorbable stent may notoutlive its usefulness within the vessel. Moreover, a bioresorbablestent may be used to deliver a greater dose of a therapeutic agent,deliver multiple therapeutic agents at the same time or at various timesof its life cycle, to treat specific aspects or events of vasculardisease. Additionally, a bioresorbable stent may also allow for repeattreatment of the same approximate region of the blood vessel.Accordingly, there remains an important unmet need to develop temporary(i.e., bioresorbable) and radiopaque stents, wherein the polymericmaterials used to fabricate these stents have the desirable qualities ofmetal (e.g., sufficient radial strength and radiopacity, etc.), whilecircumventing or alleviating the many disadvantages or limitationsassociated with the use of permanent metal stents.

In one preferred embodiment, the stent may be formed from biocompatiblepolymers that are bio-resorbable (e.g., bio-erodible or bio-degradable).Bio-resorbable materials are preferably selected from the groupconsisting of any hydrolytically degradable and/or enzymaticallydegradable biomaterial. Examples of suitable degradable polymersinclude, but are not limited to, polyhydroxybutyrate/polyhydroxyvaleratecopolymers (PHV/PHB), polyesteramides, polylactic acid, hydroxy acids(i.e. lactide, glycolide, hydroxybutyrate), polyglycolic acid, lactonebased polymers, polycaprolactone, poly(propylene fumarate-co-ethyleneglycol)copolymer (aka fumarate anhydrides), polyamides, polyanhydrideesters, polyanhydrides, polylactic acid/polyglycolic acid with a calciumphosphate glass, polyorthesters, silk-elastin polymers,polyphosphazenes, copolymers of polylactic acid and polyglycolic acidand polycaprolactone, aliphatic polyurethanes, polyhydroxy acids,polyether esters, polyesters, polydepsidpetides, polysaccharides,polyhydroxyalkanoates, and copolymers thereof.

In one mode, the degradable materials are selected from the groupconsisting of poly(glycolide-trimethylene carbonate), poly(alkyleneoxalates), polyaspartimic acid, epolyglutarunic acid polymer,poly-p-dioxanone, poly-.beta.-dioxanone, asymmetrically 3,6-substitutedpoly-1,4-dioxane-2,5-diones, polyalkyl-2-cyanoacrylates,polydepsipeptides (glycine-DL-lactide copolymer), polydihydropyranes,polyalkyl-2-cyanoacrylates, poly-.beta.-maleic acid (PMLA),polyalkanotes and poly-.beta.-alkanoic acids. There are many otherdegradable materials known in the art. (See e.g., Biomaterials Science:An Introduction to Materials in Medicine (29 Jul., 2004) Ratner,Hoffman, Schoen, and Lemons; and Atala, A., Mooney, D. SyntheticBiodegradable Polymer Scaffolds. 1997 Birkhauser, Boston; incorporatedherein by reference).

Further still, in a more preferred embodiment, the stents may be formedof a polycarbonate material, such as, for example, tyrosine-derivedpolycarbonates, tyrosine-derived polyarylates, iodinated and/orbrominated tyrosine-derived polycarbonates, iodinated and/or brominatedtyrosine-derived polyarylates. For additional information, see U.S. Pat.Nos. 5,099,060, 5,198,507, 5,587,507, 5,658,995, 6,048,521, 6,120,491,6,319,492, 6,475,477, 5,317,077, and 5,216,115, each of which isincorporated by reference herein. In another preferred embodiment, thepolymer is any of the biocompatible, bioabsorbable, radiopaque polymersdisclosed in U.S. Patent Application Nos. 60/601,526; 60/586,796; and10/952,202 the entire disclosures of which are incorporated herein byreference thereto.

Natural polymers (biopolymers) include any protein or peptide. Preferredbiopolymers may be selected from the group consisting of alginate,cellulose and ester, chitosan, collagen, dextran, elastin, fibrin,gelatin, hyaluronic acid, hydroxyapatite, spider silk, cotton, otherpolypeptides and proteins, and any combinations thereof.

In yet another alternative embodiment, shape-shifting polymers may beused to fabricate stents constructed according to the present invention.Suitable shape-shifting polymers may be selected from the groupconsisting of polyhydroxy acids, polyorthoesters, polyether esters,polyesters, polyamides, polyesteramides, polydepsidpetides, aliphaticpolyurethanes, polysaccharides, polyhydroxyalkanoates, and copolymersthereof. For addition disclosure on bio-degradable shape-shiftingpolymers, see U.S. Pat. No. 6,160,084, which is incorporated byreference herein. For additional disclosure on shape memory polymers,see U.S. Pat. Nos. 6,388,043 and 6,720,402, each of which areincorporated by reference herein. Further the transition temperature maybe set such that the stent is in a collapsed condition at a normal bodytemperature. However, with the application of heat during stentplacement and delivery, such as via a hot balloon catheter or a hotliquid (e.g., saline) perfusion system, the stent expands to assume itsfinal diameter in the body lumen. When a thermal memory material isused, it may provide a crush-recoverable structure.

Further still, stents may be formed from biocompatible polymers that arebiostable (e.g., non-degrading and non-erodible). Examples of suitablenon-degrading materials include, but are not limited to, polyurethane,Delrin, high density polyethylene, polypropylene, and poly(dimethylsiloxane).

In some embodiments, the layers may comprise or contain any example ofthermoplastics, such as the following, among others: fluorinatedethylene-propylene, poly(2-hydroxyethlmethacrylate (aka pHEMA),poly(ethylene terephthalate) fiber (aka Dacron®) or film (Mylar®),poly(methyl methacrylate (aka PMMA), Poly(tetraflouroethylene) (aka PTFEand ePTFE and Gore-Tex®), poly(vinylchloride), polyacrylates andpolyacrylonitrile (PAN), polyamides (aka Nylon), polycarbonates andpolycarbonate urethanes, polyethylene and poly(ethylene-co-vinylacetate), polypropylene, polypropylene, polystyrene, polysulphone,polyurethane and polyetherurethane elastomers such as Pellethane® andEstane®, Silicone rubbers, Siloxane, polydimethylsiloxane (aka PDMS),Silastic®, Siliconized Polyurethane.

Methods of Manufacturing and Assembling Polymeric Stents

Where plastic and/or degradable materials are used, the elements may bemade using laser ablation with a screen, stencil or mask; solventcasting; forming by stamping, embossing, compression molding,centripetal spin casting and molding; extrusion and cutting,three-dimensional rapid prototyping using solid free-form fabricationtechnology, stereolithography, selective laser sintering, or the like;etching techniques comprising plasma etching; textile manufacturingmethods comprising felting, knitting, or weaving; molding techniquescomprising fused deposition modeling, injection molding, roomtemperature vulcanized molding, or silicone rubber molding; castingtechniques comprising casting with solvents, direct shell productioncasting, investment casting, pressure die casting, resin injection,resin processing electroforming, or injection molding or reactioninjection molding. Certain preferred embodiments with the presentpolymers may be shaped into stents via combinations of two or morethereof, and the like.

Such processes may further include two-dimensional methods offabrication such as cutting extruded sheets of polymer, via lasercutting, etching, mechanical cutting, or other methods, and assemblingthe resulting cut portions into stents, or similar methods ofthree-dimensional fabrication of devices from solid forms. Foradditional information, see U.S. patent application Ser. No. 10/655,338,which is incorporated by reference herein.

Stents of the preferred embodiment are manufactured with elementsprepared in full stent lengths or in partial lengths of which two ormore are then connected or attached. If using partial lengths, two ormore may be connected or attached to comprise a full length stent. Inthis arrangement the parts are assembled to give rise to a centralopening. The assembled full or partial length parts and/or modules maybe assembled by inter-weaving them in various states, from a collapsedstate, to a partially expanded state, to an expanded state.

Further, elements may be connected or attached by solvent or thermalbonding, or by mechanical attachment. If bonding, preferred methods ofbonding comprise the use of ultrasonic radiofrequency or other thermalmethods, and by solvents or adhesives or ultraviolet curing processes orphotoreactive processes. The elements may be rolled by thermal forming,cold forming, solvent weakening forming and evaporation, or bypreforming parts before linking.

Another method of manufacture allows for assembly of the stentcomponents that have been cut out and assembled into flat series ofradial elements. The linkage elements between longitudinally adjacentseries of radial elements may be connected (e.g., by welding,inter-weaving frame elements, etc.), the flat sheets of material arerolled to form a tubular member. Coupling arms from floating couplingelements and end portions may be joined (e.g., by welding) to maintainthe tubular shape. In embodiments that do not include coupling elements,the end portions of the top and bottom radial elements in a series maybe joined. Alternatively, where sliding is desired throughout the entirecircumference, a sliding and locking articulation can be made betweenthe end portion of the top radial element and the rib(s)/rails of thebottom radial element (e.g., by tack-welding, heat-staking orsnap-together). Similarly, a corresponding articulation can be madebetween the end portion of the bottom radial element and therib(s)/rails of the top radial element.

Rolling of the flat series of module(s) to form a tubular member can beaccomplished by any means known in the art, including rolling betweentwo plates, which are each padded on the side in contact with the stentelements. One plate is held immobile and the other can move laterallywith respect to the other. Thus, the stent elements sandwiched betweenthe plates may be rolled about a mandrel by the movement of the platesrelative to one another. Alternatively, 3-way spindle methods known inthe art may also be used to roll the tubular member. Other rollingmethods that may be used in accordance with the present inventioninclude those used for “jelly-roll” designs, as disclosed for example,in U.S. Pat. Nos. 5,421,955, 5,441,515, 5,618,299, 5,443,500, 5,649,977,5,643,314 and 5,735,872; the disclosures of which are incorporatedherein in their entireties by reference thereto.

The construction of the slide-and-lock stents in these fashions providesa great deal of benefit over the prior art. The construction of thelocking mechanism is largely material-independent. This allows thestructure of the stent to comprise high strength materials, not possiblewith designs that require deformation of the material to complete thelocking mechanism. The incorporation of these materials will allow thethickness required of the material to decrease, while retaining thestrength characteristics of thicker stents. In preferred embodiments,the frequency of catches, stops or teeth present on selectedcircumferential elements prevents unnecessary recoil of the stentsubsequent to expansion.

Radiopacity

Traditional methods for adding radiopacity to a medical product includethe use of metal bands, inserts and/or markers, electrochemicaldeposition (i.e., electroplating), or coatings. The addition ofradiopacifiers (i.e., radiopaque materials) to facilitate tracking andpositioning of the stent could be accommodated by adding such an elementin any fabrication method, by absorbing into or spraying onto thesurface of part or all of the device. The degree of radiopacity contrastcan be altered by element content.

For plastics and coatings, radiopacity may be imparted by use ofmonomers or polymers comprising iodine or other radiopaque elements,i.e., inherently radiopaque materials. Common radiopaque materialsinclude barium sulfate, bismuth subcarbonate, and zirconium dioxide.Other radiopaque elements include: cadmium, tungsten, gold, tantalum,bismuth, platium, iridium, and rhodium. In one preferred embodiment, ahalogen such as iodine and/or bromine may be employed for itsradiopacity and antimicrobial properties.

Multi-Material Vascular Prosthesis

In still other alternative embodiments, various materials (e.g., metals,polymers, ceramics, and therapeutic agents) may be used to fabricatestent embodiments. The embodiments may comprise: 1) differentiallylayered materials (through the vertical or radial axis) to create astack of materials (materials may be stacked in any configuration, e.g.,parallel, staggered, etc.); 2) spatially localized materials which mayvary along the long axis and/or thickness of the stent body; 3)materials that are mixed or fused to create a composite stent body; 4)embodiments whereby a material is laminated (or coated) on the surfaceof the stent body (see Stent Surface Coatings with Functional Propertiesas well as see Therapeutic Agents Delivered by Stents); and, 5) stentscomprised of 2 or more parts where at least one part is materiallydistinct from a second part, or any combination thereof.

The fashioning of a slide-and-lock multi-material stent can have betweentwo or more materials. Thickness of each material may vary relative toother materials. This approach as needed or desired allows an overallstructural member to be built with each material having one or morefunctions contributing towards enabling prosthesis function whichincludes, but is not limited to: 1) enabling mechanical properties forstent performance as defined by ultimate tensile strength, yieldstrength, Young's modulus, elongation at yield, elongation at break, andPoisson's ratio; 2) enabling the thickness of the substrate, geometricalshape (e.g., bifurcated, variable surface coverage); 3) enablingchemical properties of the material that bear relevance to the materialsperformance and physical state such as rate of degradation andresorption (which may impact therapeutic delivery), glass transitiontemperature, melting temperature, molecular weight; 4) enablingradiopacity or other forms of visibility and detection; 5) enablingradiation emission; 6) enabling delivery of a therapeutic agent (seeTherapeutic Agents Delivered by Stents); and 7) enabling stent retentionand/or other functional properties (see Stent Surface Coatings withFunctional Properties).

In some embodiments, the materials may comprise load-bearing properties,elastomeric properties, mechanical strength that is specific to adirection or orientation e.g., parallel to another material and/or tothe long axis of the stent, or perpendicular or uniform strength toanother material and/or stent. The materials may comprise stiffeners,such as the following, boron or carbon fibers, pyrolytic carbon.Further, stents may be comprised of at least one re-inforcement such afibers, nanoparticles or the like.

In another preferred mode of the invention, the stent is made, at leastin part, from a polymeric material, which may be degradable. Themotivation for using a degradable stent is that the mechanical supportof a stent may only be necessary for several weeks. In some embodiments,bioresorbable materials with varying rates of resorption may beemployed. For additional information, see U.S. patent application Ser.No. 10/952,202 and 60/601,526, which are incorporated by referenceherein. Degradable polymeric stent materials may be particularly usefulif it also controls restenosis and thrombosis by deliveringpharmacologic agents. Degradable materials are well suited fortherapeutic delivery (see Therapeutic Agents Delivered by Stents).

In some embodiments, the materials may comprise or contain any class ofdegradable polymer as previously defined. Along with variation in thetime of degradation and/or resorption the degradable polymer may haveother qualities that are desirable. For example, in some embodiments thematerials may comprise or contain any example of natural polymers(biopolymers) and/or those that degrade by hydrolytic and/or enzymaticaction. In some embodiments, the material may comprise or contain anyexample of hydrogels that may or may not be thermally reversiblehydrogels, or any example of a light or energy curable material, ormagnetically stimulateable (responding) material. Each of theseresponses may provide for a specific functionality.

In some embodiments, the materials may comprise or be made from or withconstituents which has some radiopaque material alternatively, aclinically visible material which is visible by x-ray, fluoroscopy,ultrasound, MRI, or Imatron Electron Beam Tomography (EBT).

In some embodiments, one or more of the materials may emit predeterminedor prescribed levels of therapeutic radiation. In one embodiment, thematerial can be charged with beta radiation. In another embodiment, thematerial can be charged with Gamma radiation. In yet another embodiment,the material can be charged with a combination of both Beta and Gammaradiation. Stent radioisotopes that may be used include, but are notlimited to, 103Pd and 32P (phosphorus-32) and two neutron-activatedexamples, 65Cu and 87Rb2O, (90)Sr, tungsten-188 (188).

In some embodiments, one or more of the materials may comprise orcontain a therapeutic agent. The therapeutic agents may have unique,delivery kinetics, mode of action, dose, half-life, purpose, et cetera.In some embodiments, one or more of the materials comprise an agentwhich provides a mode and site of action for therapy for example by amode of action in the extracellular space, cell membrane, cytoplasm,nucleus and/or other intracellular organelle. Additionally an agent thatserves as a chemoattractant for specific cell types to influence tissueformation and cellular responses for example host-biomaterialinteractions, including anti-cancer effects. In some embodiments, one ormore of the materials deliver cells in any form or state of developmentor origin. These could for example be encapsulated in a degradablemicrosphere, or mixed directly with polymer, or hydrogel and serve asvehicle for pharmaceutical delivery. Living cells could be used tocontinuously deliver pharmaceutical type molecules, for instance,cytokines and growth factors. Nonliving cells may serve as a limitedrelease system. For additional concepts of therapeutic delivery, see thesection entitled: Therapeutic Agents Delivered by Stents.

Therapeutic Agents Delivered by Stents

In another preferred variation, the stent further comprises an amount ofa therapeutic agent (as previously defined for a pharmaceutical agentand/or a biologic agent) sufficient to exert a selected therapeuticeffect. In some preferred embodiments of the stent (e.g., polymer stentsand multi-material stents) the therapeutic agent is contained within thestent as the agent is blended with the polymer or admixed by other meansknown to those skilled in the art. In other preferred embodiments of thestent, the therapeutic agent is delivered from a polymer coating on thestent surface. In some preferred embodiments of the stent a therapeuticagent is localized in or around a specific structural aspect of thedevice.

In another preferred variation the therapeutic agent is delivered bymeans of a non-polymer coating. In other preferred embodiments of thestent, the therapeutic agent is delivered from at least one region orone surface of the stent. The therapeutic can be chemically bonded tothe polymer or carrier used for delivery of the therapeutic from atleast one portion of the stent and/or the therapeutic can be chemicallybonded to the polymer that comprises at least one portion of the stentbody. In one preferred embodiment, more than one therapeutic agent maybe delivered.

The amount of the therapeutic agent is preferably sufficient to inhibitrestenosis or thrombosis or to affect some other state of the stentedtissue, for instance, heal a vulnerable plaque, and/or prevent ruptureor stimulate endothelialization or limit other cell types fromproliferating and from producing and depositing extracellular matrixmolecules. The agent(s) may be selected from the group consisting ofantiproliferative agents, anti-inflammatory, anti-matrixmetalloproteinase, and lipid lowering, cholesterol modifying,anti-thrombotic and antiplatelet agents, in accordance with preferredembodiments of the present invention. Some of these preferredanti-proliferative agents that improve vascular patency include withoutlimitation paclitaxel, Rapamycin, ABT-578, everolimus, dexamethasone,nitric oxide modulating molecules for endothelial function, tacrolimus,estradiol, mycophenolic acid, C6-ceramide, actinomycin-D andepothilones, and derivatives and analogs of each.

Some of these preferred agents act as an antiplatelet agent,antithrombin agent, compounds to address other pathologic events and/orvascular diseases. Various therapeutic agents may be classified in termsof their sites of action in the host: agents that exert their actionsextracellularly or at specific membrane receptor sites, those that acton the plasma membrane, within the cytoplasm, and/or the nucleus.

In addition to the aforementioned, therapeutic agents may include otherpharmaceutical and/or biologic agents intended for purposes of treatingbody lumens other than arteries and/or veins). Therapeutic agents may bespecific for treating nonvascular body lumens such as digestive lumens(e.g., gastrointestinal, duodenum and esophagus, biliary ducts),respiratory lumens (e.g., tracheal and bronchial), and urinary lumens(e.g., urethra). Additionally such embodiments may be useful in lumensof other body systems such as the reproductive, endocrine, hematopoieticand/or the integumentary, musculoskeletal/orthopedic and nervous systems(including auditory and ophthalmic applications); and finally, stentembodiments with therapeutic agents may be useful for expanding anobstructed lumen and for inducing an obstruction (e.g., as in the caseof aneurysms).

Therapeutic release may occur by controlled release mechanisms,diffusion, interaction with another agent(s) delivered by intravenousinjection, aerosolization, or orally. Release may also occur byapplication of a magnetic field, an electrical field, or use ofultrasound.

Stent Surface Coatings with Functional Properties

In addition to stents that may deliver a therapeutic agent, for instancedelivery of a biological polymer on the stent such as a repellantphosphorylcholine, the stent may be coated with other bioresorbablepolymers predetermined to promote biological responses in the body lumendesired for certain clinical effectiveness. Further the coating may beused to mask (temporarily or permanently) the surface properties of thepolymer used to comprise the stent embodiment. The coating may beselected from the broad class of any biocompatible bioresorbable polymerwhich may include any one or combination of halogenated and/ornon-halogenated which may or may not comprise any poly(alkylene glycol).These polymers may include compositional variations includinghomopolymers and heteropolymers, stereoisomers and/or a blend of suchpolymers. These polymers may include for example, but are not limitedto, polycarbonates, polyarylates, poly(ester amides), poly(amidecarbonates), trimethylene carbonate, polycaprolactone, polydioxane,polyhydroxybutyrate, poly-hydroxyvalerate, polyglycolide, polylactidesand stereoisomers and copolymers thereof, such as glycolide/lactidecopolymers. In a preferred embodiment, the stent is coated with apolymer that exhibits a negative charge that repels the negativelycharged red blood cells' outer membranes thereby reducing the risk ofclot formation. In another preferred embodiment, the stent is coatedwith a polymer that exhibits an affinity for cells, (e.g., endothelialcells) to promote healing. In yet another preferred embodiment, thestent is coated with a polymer that repels the attachment and/orproliferation of specific cells, for instance arterial fibroblastsand/or smooth muscle cells in order to lessen restenosis and/orinflammatory cells such as macrophages.

Described above are the stents of the present invention that may bemodified with a coating to achieve functional properties that supportbiological responses. Such coatings or compositions of material with atherapeutic agent may be formed on stents or applied in the process ofmaking a stent body via techniques such as dipping, spray coating,cross-linking combinations thereof, and the like. Such coatings orcompositions of material may also serve purpose other than delivering atherapeutic, such as to enhance stent retention on a balloon when thecoating is placed intraluminally on the stent body and/or placed overthe entire device after the stent is mounted on the balloon system tokeep the stent in a collapsed formation. Other purposes can beenvisioned by those skilled in the art when using any polymer material.

In one aspect of the invention, a stent would have a coating appliedthat has specific mechanical properties. The properties may includeinter alia thickness, tensile strength, glass transition temperature,and surface finish. The coating is preferably applied prior to finalcrimping or application of the stent to the catheter. The stent may thenbe applied to the catheter and the system may have either heat orpressure or both applied in a compressive manner. In the process, thecoating may form frangible bonds with both the catheter and the otherstent surfaces. The bonds would enable a reliable method of creatingstent retention and of holding the stent crossing profile over time. Thebonds would break upon the balloon deployment pressures. The coatingwould be a lower Tg than the substrate to ensure no changes in thesubstrate.

Stent Deployment

First, a catheter is provided wherein an expandable member, preferablyan inflatable balloon, such as an angioplasty balloon, is provided alonga distal end portion. One example of a balloon catheter for use with astent is described in U.S. Pat. No. 4,733,665 to Palmaz, which isincorporated by reference herein. A stent on a catheter is commonlycollectively referred to as a stent system. Catheters include but arenot limited to over-the-wire catheters, coaxial rapid-exchange designsand the Medtronic Zipper Technology that is a new delivery platform.Such catheters may include for instance those described in Bonzel U.S.Pat. Nos. 4,762,129 and 5,232,445 and by Yock U.S. Pat. Nos. 4,748,982;5,496,346; 5,626,600; 5,040,548; 5,061,273; 5,350,395; 5,451,233 and5,749,888. Additionally, catheters may include for instance those asdescribed in U.S. Pat. Nos. 4,762,129; 5,092,877; 5,108,416; 5,197,978;5,232,445; 5,300,085; 5,445,646; 5,496,275; 5,545,135; 5,545,138;5,549,556; 5,755,708; 5,769,868; 5,800,393; 5,836,965; 5,989,280;6,019,785; 6,036,715; 5,242,399; 5,158,548; and 6,007,545. Thedisclosures of the above-cited patents are incorporated herein in theirentirety by reference thereto.

Catheters may be specialized with highly compliant polymers and forvarious purposes such as to produce an ultrasound effect, electricfield, magnetic field, light and/or temperature effect. Heatingcatheters may include for example those described in U.S. Pat. Nos.5,151,100, 5,230,349; 6,447,508; and 6,562,021 as well as WO9014046A1.Infrared light emitting catheters may include for example thosedescribed in U.S. Pat. Nos. 5,910,816 and 5,423,321. The disclosures ofthe above-cited patents and patent publications are incorporated hereinin their entirety by reference thereto.

An expandable member, such as an inflatable balloon, is preferably usedto deploy the stent at the treatment site. As the balloon is expanded,the radial force of the balloon overcomes the initial resistance of theconstraining mechanism, thereby allowing the stent to expand. As theballoon is inflated, the radial elements slide with respect to eachother along the surface of the balloon until the stent has been expandedto a desired diameter.

The stent of embodiments of the invention are adapted for deploymentusing conventional methods known in the art and employing percutaneoustransluminal catheter devices. This includes deployment in a body lumenby means of a balloon expandable design whereby expansion is driven bythe balloon expanding. Alternatively, the stent may be mounted onto acatheter that holds the stent as it is delivered through the body lumenand then releases the stent and allows it to self-expand into contactwith the body lumen. The restraining means may comprise a removablesheath and/or a mechanical aspect of the stent design.

Some embodiments of the invention may be useful in coronary arteries,carotid arteries, vascular aneurysms (when covered with a sheath), andperipheral arteries and veins (e.g., renal, iliac, femoral, popliteal,subclavian, aorta, intercranial, etc.). Other nonvascular applicationsinclude gastrointestinal, duodenum, biliary ducts, esophagus, urethra,reproductive tracts, trachea, and respiratory (e.g., bronchial) ducts.These applications may or may not require a sheath covering the stent.

It is desirable to have the stent radially expand in a uniform manner.Alternatively, the expanded diameter may be variable and determined bythe internal diameter and anatomy of the body passageway to be treated.Accordingly, uniform and variable expansion of the stent that iscontrolled during deployment is not likely to cause a rupture of thebody passageway. Furthermore, the stent will resist recoil because thelocking means resist sliding of the mating elements. Thus, the expandedintraluminal stent will continue to exert radial pressure outwardagainst the wall of the body passageway and will therefore, not migrateaway from the desired location.

From the foregoing description, it will be appreciated that a novelapproach for expanding a lumen has been disclosed. While the components,techniques and aspects of the invention have been described with acertain degree of particularity, it is manifest that many changes may bemade in the specific designs, constructions and methodology herein abovedescribed without departing from the spirit and scope of thisdisclosure.

While a number of preferred embodiments of the invention and variationsthereof have been described in detail, other modifications and methodsof using and medical applications for the same will be apparent to thoseof skill in the art. Accordingly, it should be understood that variousapplications, modifications, materials, and substitutions may be made ofequivalents without departing from the spirit of the invention or thescope of the claims.

Various modifications and applications of the invention may occur tothose who are skilled in the art, without departing from the true spiritor scope of the invention. It should be understood that the invention isnot limited to the embodiments set forth herein for purposes ofexemplification, but is to be defined only by a fair reading of theappended claims, including the full range of equivalency to which eachelement thereof is entitled.

The stent preferably comprises at least one longitudinal module, whichconsists of a series of radial elements, including one or moreslide-and-lock radial elements and optionally one or more passive radialelements, linked in the longitudinal axis by flexible coupling portions.Preferably, the radial elements from two or more similar longitudinalmodules are slidably connected to circumferentially adjacent radialelements. Of course, single module (or jellyroll-type) embodiments arealso encompassed within the scope of the present disclosure. Each moduleis preferably a discrete, unitary structure that does not stretch orotherwise exhibit any substantial permanent deformation during stentdeployment.

REFERENCES

Some of the references cited herein are listed below, the entirety ofeach one of which is hereby incorporated by reference herein:

-   -   Charles R, Sandirasegarane L, Yun J, Bourbon N, Wilson R,        Rothstein R P, et al. Ceramide-Coated Balloon Catheters Limit        Neointimal Hyperplasia after Stretch Injury in Carotid Arteries.        Circ Res 2000;87(4):282-288.    -   Coroneos E, Martinez M, McKenna S, Kester M. Differential        regulation of sphingomyelinase and ceramidase activities by        growth factors and cytokines. Implications for cellular        proliferation and differentiation. J Biol Chem        1995;270(40):23305-9.    -   Coroneos E, Wang Y, Panuska J R, Templeton D J, Kester M.        Sphingolipid metabolites differentially regulate extracellular        signal-regulated kinase and stress-activated protein kinase        cascades. Biochem J 1996;316(Pt 1):13-7.    -   Jacobs L S, Kester M. Sphingolipids as mediators of effects of        platelet-derived growth factor in vascular smooth muscle cells.        Am J Physiol 1993;265(3 Pt 1):C740-7.    -   Tanguay J F, Zidar J P, Phillips H R, 3rd, Stack R S. Current        status of biodegradable stents. Cardiol Clin 1994;12(4):699-713.    -   Nikol S, Huehns T Y, Hofling B. Molecular biology and        post-angioplasty restenosis. Atherosclerosis 1996; 123(1-2):        17-31.    -   Biomaterials Science: An Introduction to Materials in Medicine        (29 Jul., 2004) Ratner, Hoffman, Schoen, and Lemons

1. A slide-and-lock stent, comprising a tubular member having alongitudinal axis, said tubular member comprising: a first radialelement comprising an elongate rail comprising a deflectable tooth,wherein said elongate rail defines upper and lower portions and firstand second ends, said upper portion tapering circumferentially from afirst radial thickness to a second radial thickness in a first directionapproaching a distal edge of said upper portion, said lower portiontapering circumferentially from said first radial thickness to saidsecond radial thickness in a direction opposite the first directionapproaching a distal edge of said lower portion, the first radialelement not overlapping itself when the stent is in an expanded state; asecond radial element comprising an engagement means configured tocircumferentially overlap and slidably engage said elongate rail of thefirst radial element in an expanded state to define an overlappedsection of the elongate rail, said engagement means configured todeflect said deflectable tooth as the tooth contacts said engagementmeans such that said tubular member achieves circumferential expansionwith reduced recoil, wherein said overlapped section of the elongaterail of the first radial element tapers along substantially its entirelength for reducing a radial thickness of the stent; and a flexiblelinkage element engaging the first and second ends of the elongate railof the first radial element, the first end comprising the distal edge ofthe upper portion and the second end comprising the distal edge of thelower portion.
 2. The slide-and-lock stent of claim 1 wherein saidengagement means comprises a closed loop which defines a slot.
 3. Theslide-and-lock stent of claim 1, wherein said second radial thickness isapproximately one-half of said first radial thickness.
 4. Theslide-and-lock stent of claim 2, wherein said lower portion defines agenerally constant taper from said first radial thickness to said secondradial thickness.
 5. The slide-and-lock stent of claim 1, wherein saidengagement means tapers circumferentially.
 6. The slide-and-lock stentof claim 5, wherein said engagement means tapers circumferentially tosaid second thickness approaching a distal edge of said engagementmeans.
 7. The stent of claim 1, wherein the first radial element furthercomprises an engagement means configured to slidably engage a thirdradial element.
 8. The stent of claim 1, wherein at least one of thefirst and second radial elements further comprises a radiallynon-tapered portion.
 9. The stent of claim 1, wherein the engagementmeans is configured to deflect the deflectable tooth in a directiongenerally parallel to the longitudinal axis.
 10. The stent of claim 1,wherein the engagement means does not include paired slots.
 11. Aslide-and-lock stent, comprising a tubular member having a longitudinalaxis, said tubular member comprising: a first radial element comprisingan elongate rail comprising a plurality of deflectable teeth, the firstradial element not overlapping itself when the stent is in an expandedstate; and a second radial element, circumferentially adjacent to thefirst radial element, and comprising an elongate rail and an engagementmeans comprising a slot configured to slidably engage said elongate railof the first radial element and deflect said deflectable teeth in adirection generally parallel to the longitudinal axis as said elongaterail of the first radial element passes through the slot such that saidtubular member achieves circumferential expansion with reduced recoil,the second radial element not overlapping itself when the stent is inthe expanded state; wherein said elongate rail of said first elementdefines upper and lower portions and a first radial thickness, saidupper portion tapering circumferentially from said first thickness to asecond radial thickness in a first direction approaching a distal edgeof said upper portion, said lower portion tapers circumferentially fromsaid first radial thickness to said second radical thickness in adirection opposite the first direction approaching a distal edge of saidlower portion; and wherein said second radical element overlaps with thefirst radial element in an expanded state to define an overlappedsection of the first radial element, and wherein the overlapped sectiontapers along substantially its entire length for reducing a radialthickness of the stent when the stent is in the expanded state.
 12. Thestent of claim 11, wherein said elongate rail of said first radialelement further comprises two rail members with a gap being disposedtherebetween, said rail members deflecting toward one another into thegap when engaged by the slot of the second radial element.
 13. The stentof claim 11, wherein said second radial thickness is approximatelyone-half of said first radial thickness.
 14. The stent of claim 11,wherein the first and second radial elements are structurally separatefrom one another.
 15. The stent of claim 11, wherein the engagementmeans comprises an offset portion that is radially offset from theelongate rail of the second radial element, the offset portion and theelongate rail of the second radial element being disposed on opposingsides of the elongate rail of the first radial element when the firstradial element is engaged by the second radial element.
 16. The stent ofclaim 11, wherein a combined radial thickness of the first and secondradial elements in the overlapped section does not exceed 1 ½ of thefirst radial thickness.
 17. The stent of claim 11, wherein at least oneof the first and second radial elements further comprise a radiallynon-tapered portion.
 18. The stent of claim 11, wherein the engagementmeans does not include paired slots.
 19. The stent of claim 11, whereinthe elongate rail further comprises a first end and a second end, thefirst end comprising the distal edge of the upper portion and the secondend comprising the distal edge of the lower portion, the first andsecond ends being engaged by a flexible linkage element.
 20. Aslide-and-lock stent, comprising: a first radial element comprising afirst elongate rail, the first elongate rail defining a first taperedsection having a radial thickness that tapers in a first circumferentialdirection, the first radial element comprising an engagement structuredisposed along the first tapered section; and a second radial elementcomprising a second elongate rail, the second elongate rail defining asecond tapered section having a radial thickness that tapers in a secondcircumferential direction that is generally opposite to the firstcircumferential direction, the second radial element comprising anengagement means configured to slidably engage the engagement structureof the first elongate rail such that the stent achieves expansion withreduced recoil, the engagement means not including paired slots; whereinthe second tapered section circumferentially overlaps the first taperedsection when the stent is in an expanded state and the first and secondtapered sections taper along substantially their entire length tominimize a combined radial thickness of the first and second taperedsections for reducing the radial thickness of the stent at theoverlapping first and second tapered sections of the first and secondradial elements.
 21. The stent of claim 20, wherein the first and secondtapered sections overlap only each other.
 22. The stent of claim 21,wherein the first and second radial elements are structurally separatefrom one another.
 23. The stent of claim 20, wherein the first andsecond radial elements do not overlap with themselves when the stent isin the expanded state.
 24. The stent of claim 20, wherein the engagementmeans of the second radial element comprises an offset buckle portionbeing radially offset from the second elongate rail without the secondradial element overlapping itself, the offset buckle portion and thesecond elongate rail being disposed on opposing sides of the firstelongate rail of the first radial element when the first radial elementis engaged by the second radial element.
 25. The stent of claim 20,wherein the engagement means comprises a slot and the engagementstructure comprises at least one tooth.
 26. The stent of claim 20,wherein the engagement means is disposed adjacent to the second taperedsection of the second radial element.
 27. The stent of claim 20, whereinthe first and second tapered sections taper from a first radialthickness to a second radial thickness, wherein the combined radialthickness of the first and second tapered sections along overlap thereofdoes not exceed the sum of the first and second radial thicknesses whenthe stent is in the expanded state.
 28. The stent of claim 20, whereinthe combined radial thickness of overlapping first and second taperedsections does not exceed 1 ½ of a maximum thickness of the first radialelement.
 29. The stent of claim 20, wherein at least one of the firstand second radial elements further comprise a radially non-taperedportion.
 30. The stent of claim 20, wherein: the first elongate railfurther comprises circumferentially spaced apart first and second ends,the first and second ends engaged by a flexible linkage element.
 31. Thestent of claim 20, wherein the slide-and-lock stent has a longitudinalaxis, the engagement structure of the first elongate rail comprises adeflectable tooth, and the engagement means of the second radial elementis configured to deflect the deflectable tooth in a direction generallyparallel to the longitudinal axis.
 32. A slide-and-lock stent,comprising a tubular member having a longitudinal axis, said tubularmember comprising: a first radial element comprising an elongate railcomprising a deflectable tooth, wherein said elongate rail defines upperand lower portions, said upper portion tapering circumferentially from afirst radial thickness to a second radial thickness in a first directionapproaching a distal edge of said upper portion, said lower portiontapering circumferentially from said first radial thickness to saidsecond radial thickness in a direction opposite the first directionapproaching a distal edge of said lower portion, the first radialelement not overlapping itself when the stent is in an expanded state;and a second radial element comprising an engagement means configured tocircumferentially overlap and slidably engage said elongate rail of thefirst radial element in an expanded state to define an overlappedsection of the elongate rail, said engagement means configured todeflect said deflectable tooth as the tooth contacts said engagementmeans such that said tubular member achieves circumferential expansionwith reduced recoil, wherein said overlapped section of the elongaterail of the first radial element tapers along substantially its entirelength for reducing a radial thickness of the stent; wherein saidengagement means tapers circumferentially from a radial thickness ofapproximately 1 1/2 of said first radial thickness to said second radialthickness approaching a distal edge of said engagement means.
 33. Aslide-and-lock stent, comprising a tubular member having a longitudinalaxis, said tubular member comprising: a first radial element comprisingan elongate rail comprising a deflectable tooth, wherein said elongaterail defines upper and lower portions, said upper portion taperingcircumferentially from a first radial thickness to a second radialthickness in a first direction approaching a distal edge of said upperportion, said lower portion tapering circumferentially from said firstradial thickness to said second radial thickness in a direction oppositethe first direction approaching a distal edge of said lower portion, thefirst radial element not overlapping itself when the stent is in anexpanded state; and a second radial element comprising an engagementmeans configured to circumferentially overlap and slidably engage saidelongate rail of the first radial element in an expanded state to definean overlapped section of the elongate rail, said engagement meansconfigured to deflect said deflectable tooth as the tooth contacts saidengagement means such that said tubular member achieves circumferentialexpansion with reduced recoil, wherein said overlapped section of theelongate rail of the first radial element tapers along substantially itsentire length for reducing a radial thickness of the stent; wherein acombined radial thickness of the overlapped section of the first radialelement and the second radial element does not exceed 1 ½ of the firstradial thickness.
 34. A slide-and-lock stent, comprising a tubularmember having a longitudinal axis, said tubular member comprising: afirst radial element comprising an elongate rail comprising adeflectable tooth, wherein said elongate rail defines upper and lowerportions, said upper portion tapering circumferentially from a firstradial thickness to a second radial thickness in a first directionapproaching a distal edge of said upper portion, said lower portiontapering circumferentially from said first radial thickness to saidsecond radial thickness in a direction opposite the first directionapproaching a distal edge of said lower portion, the first radialelement not overlapping itself when the stent is in an expanded state;and a second radial element comprising an engagement means configured tocircumferentially overlap and slidably engage said elongate rail of thefirst radial element in an expanded state to define an overlappedsection of the elongate rail, said engagement means configured todeflect said deflectable tooth as the tooth contacts said engagementmeans such that said tubular member achieves circumferential expansionwith reduced recoil, wherein the engagement means tapers from a radialthickness of approximately 1 ½ of the thickness of the non-taperedportion to approximately one-half of a radial thickness of thenon-tapered portion; wherein said overlapped section of the elongaterail of the first radial element tapers along substantially its entirelength for reducing the radial thickness of the stent; and wherein atleast one of the first and second radial elements further comprises aradially non-tapered portion.
 35. A slide-and-lock stent, comprising atubular member having a longitudinal axis, said tubular membercomprising: a first radial element comprising an elongate railcomprising a plurality of deflectable teeth, the first radial elementnot overlapping itself when the stent is in an expanded state; and asecond radial element, circumferentially adjacent to the first radialelement, and comprising an elongate rail and an engagement meanscomprising a slot configured to slidably engage said elongate rail ofthe first radial element and deflect said deflectable teeth as saidelongate rail of the first radial element passes through the slot suchthat said tubular member achieves circumferential expansion with reducedrecoil, the second radial element not overlapping itself when the stentis in the expanded state; wherein said elongate rail of said firstradial element defines upper and lower portions and a first radialthickness, said upper portion tapering circumferentially from said firstradial thickness to a second radial thickness in a first directionapproaching a distal edge of said upper portion, said lower portiontapers circumferentially from said first radial thickness to said secondradial thickness in a direction opposite the first direction approachinga distal edge of said lower portion; wherein said second radial elementoverlaps with the first radial element in an expanded state to define anoverlapped section of the first radial element, and wherein theoverlapped section tapers along substantially its entire length forreducing a radial thickness of the stent when the stent is in theexpanded state; and wherein at least one of the first and second radialelements further comprise a radially non-tapered portion, and themaximum radial thickness of the stent is less than or equal toapproximately 1 ½ of the radial thickness of the non-tapered portion.36. A slide-and-lock stent, comprising: a first radial elementcomprising a first elongate rail, the first elongate rail defining afirst tapered section having a radial thickness that tapers in a firstcircumferential direction, the first radial element comprising anengagement structure disposed along the first tapered section; and asecond radial element comprising a second elongate rail, the secondelongate rail defining a second tapered section having a radialthickness that tapers in a second circumferential direction that isgenerally opposite to the first circumferential direction, the secondradial element comprising an engagement means configured to slidablyengage the engagement structure of the first elongate rail such that thestent achieves expansion with reduced recoil, wherein the engagementmeans tapers circumferentially for minimizing the combined radialthickness at the overlapping first and second tapered sections of thefirst and second radial elements; wherein the second tapered sectioncircumferentially overlaps the first tapered section when the stent isin an expanded state and the first and second tapered sections taperalong substantially their entire length to minimize a combined radialthickness of the first and second tapered sections for reducing theradial thickness of the stent at the overlapping first and secondtapered sections of the first and second radial elements.
 37. Aslide-and-lock stent, comprising: a first radial element comprising afirst elongate rail, the first elongate rail defining a first taperedsection having a radial thickness that tapers in a first circumferentialdirection, the first radial element comprising an engagement structuredisposed along the first tapered section; and a second radial elementcomprising a second elongate rail, the second elongate rail defining asecond tapered section having a radial thickness that tapers in a secondcircumferential direction that is generally opposite to the firstcircumferential direction, the second radial element comprising anengagement means configured to slidably engage the engagement structureof the first elongate rail such that the stent achieves expansion withreduced recoil; wherein the second tapered section circumferentiallyoverlaps the first tapered section when the stent is in an expandedstate and the first and second tapered sections taper alongsubstantially their entire length to minimize a combined radialthickness of the first and second tapered sections for reducing theradial thickness of the stent at the overlapping first and secondtapered sections of the first and second radial elements; wherein atleast one of the first and second radial elements further comprise aradially non-tapered portion; and wherein the first and second taperedsections taper from a first radial thickness to a second radialthickness, the combined radial thickness of the first and second taperedsections along the overlap thereof not exceeding approximately 1 ½ ofthe thickness of the non-tapered portion.